NDC Code(s) : 0409-1181-30, 0409-1176-03, 0409-1176-30, 0409-1178-03, 0409-1178-30, 0409-1179-03, 0409-1179-30, 0409-1180-59, 0409-1180-69, 0409-1362-11, 0409-1362-01, 0409-1418-11, 0409-1418-01
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1181
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
METACRESOL(UNII: GGO4Y809LO)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1181-301 in 1 CARTON 24/02/2006
130 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 02/24/2006
DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1176
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1176-3010 in 1 CARTON 25/08/2005
1NDC:0409-1176-031 mL in 1 CARTRIDGE Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 08/25/2005
DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1178
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1178-3010 in 1 CARTON 13/09/2005
1NDC:0409-1178-031 mL in 1 CARTRIDGE Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 09/13/2005
DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1179
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1179-3010 in 1 CARTON 10/12/2005
1NDC:0409-1179-031 mL in 1 CARTRIDGE Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 10/12/2005
DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1180
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1180-6910 in 1 CARTON 15/09/2005
1NDC:0409-1180-591 mL in 1 CARTRIDGE Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 09/15/2005
DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1362
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1362-0110 in 1 CELLO PACK 16/04/2021
1NDC:0409-1362-111 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021
DEMEROLMEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1418
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE(UNII: N8E7F7Q170)
(MEPERIDINE - UNII:9E338QE28F) 		MEPERIDINE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1418-0110 in 1 CELLO PACK 16/04/2021
1NDC:0409-1418-111 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021

LABELER - Hospira, Inc.(141588017)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 ANALYSIS(0409-1181, 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1362, 0409-1418), MANUFACTURE(0409-1181, 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1362, 0409-1418), PACK(0409-1181, 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1362, 0409-1418), LABEL(0409-1181, 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1362, 0409-1418)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 827731089 ANALYSIS(0409-1181, 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1362, 0409-1418)

PRINCIPAL DISPLAY PANEL

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock

Rx only
NDC 0409-1176-03

Demerol™
meperidine HCl injection, USP
25 mg/mL
CII

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PAA198797

#####AA
DMMMYYYY

PRINCIPAL DISPLAY PANEL - 25 mg/mL Cartridge Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1176-30
Contains 10 of NDC 0409-1176-03
Rx only

1 mL Single-dose

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Demerol™
meperidine
hydrochloride
injection, USP
25 mg/mL
CII

For Intramuscular, Subcutaneous, or
Intravenous Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Dist. by Hospira, Inc.,
Lake Forest, IL60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 25 mg/mL Cartridge Carton

PRINCIPAL DISPLAY PANEL

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock

Rx only
NDC 0409-1178-03

Demerol™
meperidine HCl injection, USP
50 mg/mL
CII

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PAA198798

#####AA
DMMMYYYY

PRINCIPAL DISPLAY PANEL - 50 mg/mL Cartridge Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1178-30
Contains 10 of NDC 0409-1178-03
Rx only

1 mL Single-dose

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Demerol™
meperidine
hydrochloride
injection, USP
50 mg/mL
CII

For Intramuscular, Subcutaneous, or
Intravenous Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Dist. by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 50 mg/mL Cartridge Carton

PRINCIPAL DISPLAY PANEL

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock

Rx only
NDC 0409-1179-03

Demerol™
meperidine HCl injection, USP
75 mg/mL
CII

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PAA198799

#####AA
DMMMYYYY

PRINCIPAL DISPLAY PANEL - 75 mg/mL Cartridge Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1179-30
Contains 10 of NDC 0409-1179-03
Rx only

1 mL Single-dose

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Demerol™
meperidine
hydrochloride
injection, USP
75 mg/mL
CII

For Intramuscular, Subcutaneous, or
Intravenous Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Dist. by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 75 mg/mL Cartridge Carton

PRINCIPAL DISPLAY PANEL

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock

Rx only
NDC 0409-1180-59

Demerol™
meperidine HCl injection, USP
100 mg/mL
CII

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PAA198800

#####AA
DMMMYYYY

PRINCIPAL DISPLAY PANEL - 100 mg/mL Cartridge Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1180-69
Contains 10 of NDC 0409-1180-59
Rx only

1 mL Single-dose

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Demerol™
meperidine
hydrochloride
injection, USP
100 mg/mL
CII

For Intramuscular, Subcutaneous, or
Intravenous Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Dist. by Hospira, Inc.,
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 100 mg/mL Cartridge Carton

PRINCIPAL DISPLAY PANEL

30 mL
Multiple-dose vial

NDC 0409-1181-30
Rx only

Sterile Aqueous Injection

Demerol™
meperidine hydrochloride injection, USP
1500 mg/30 mL (50 mg/mL)
CII

For Intramuscular, Subcutaneous, or Intravenous Use

Distributed by
Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 30 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1181-30
Rx only
NSN 6505-00-126-9360

30 mL Multiple-dose vial

Demerol™
meperidine
hydrochloride
injection, USP
1500 mg/30 mL
(50 mg/mL)
CII

For Intramuscular, Subcutaneous,
or Intravenous Use

Sterile Aqueous Injection

Hospira

PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton

PRINCIPAL DISPLAY PANEL

Demerol™
meperidine HCl injection, USP
CII
25 mg/mL
PAA148095

PRINCIPAL DISPLAY PANEL - 25 mg/mL Syringe Chamber Label

PRINCIPAL DISPLAY PANEL

TWIST & PULL

Tamper Seal

NDC 0409-1362-11
CII

Demerol™
meperidine HCl injection, USP

25 mg/mL

Intramuscular,
Subcutaneous, or
Intravenous Use
Rx only

1 mL Single-dose syringe

PAA148096

LOT #####AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 25 mg/mL Syringe Luer Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1362-01
Demerol™
CII
meperidine hydrochloride
injection, USP

25 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between
15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

Each mL contains 25 mg meperidine hydrochloride (equivalent to 21.79 mg
meperidine), 3.8 mg sodium chloride for isotonicity, NaOH and HCl for pH
adjustment, in water for injection.

For usual pediatric dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA189910
Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 25 mg/mL Syringe Cello Pack

PRINCIPAL DISPLAY PANEL

Demerol™
meperidine HCl injection, USP
CII
50 mg/mL
PAA148098

PRINCIPAL DISPLAY PANEL - 50 mg/mL Syringe Chamber Label

PRINCIPAL DISPLAY PANEL

TWIST & PULL

Tamper Seal

NDC 0409-1418-11
CII

Demerol™
meperidine HCl injection, USP

50 mg/mL

Intramuscular,
Subcutaneous, or
Intravenous Use
Rx only
1 mL Single-dose syringe

PAA148099

LOT #####AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 50 mg/mL Syringe Luer Label

PRINCIPAL DISPLAY PANEL

NDC 0409-1418-01
Demerol™
CII
meperidine hydrochloride
injection, USP

50 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between
15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

Each mL contains 50 mg meperidine hydrochloride (equivalent to 43.58 mg
meperidine), NaOH and HCl for pH adjustment, in water for injection.
For usual dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA189961
Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 50 mg/mL Syringe Cello Pack