NDC Code(s) : 81952-113-01, 81952-113-06, 81952-113-03, 81952-113-08, 81952-116-01, 81952-116-06, 81952-112-01, 81952-112-06, 81952-112-04, 81952-112-09, 81952-112-05, 81952-112-10, 81952-111-01, 81952-111-06, 81952-115-02, 81952-115-07, 81952-114-04, 81952-114-09
Packager : Hepalink USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Heparin SodiumHeparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81952-113
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM(UNII: ZZ45AB24CA)
(HEPARIN - UNII:T2410KM04A) 		HEPARIN10000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.15 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81952-113-0625 in 1 CARTON 06/12/2014
1NDC:81952-113-011 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
2NDC:81952-113-0825 in 1 CARTON 06/12/2014
2NDC:81952-113-035 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
ANDA ANDA203198 06/12/2014
Heparin SodiumHeparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81952-116
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM(UNII: ZZ45AB24CA)
(HEPARIN - UNII:T2410KM04A) 		HEPARIN20000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.15 mg in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81952-116-0625 in 1 CARTON 06/12/2014
1NDC:81952-116-011 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
ANDA ANDA203198 06/12/2014
Heparin SodiumHeparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81952-112
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM(UNII: ZZ45AB24CA)
(HEPARIN - UNII:T2410KM04A) 		HEPARIN1000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.15 mg in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81952-112-0625 in 1 CARTON 06/12/2014
1NDC:81952-112-011 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
2NDC:81952-112-0925 in 1 CARTON 06/12/2014
2NDC:81952-112-0410 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
3NDC:81952-112-1025 in 1 CARTON 06/12/2014
3NDC:81952-112-0530 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
ANDA ANDA202957 06/12/2014
Heparin SodiumHeparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81952-111
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM(UNII: ZZ45AB24CA)
(HEPARIN - UNII:T2410KM04A) 		HEPARIN5000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)5 mg in 1 mL
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.15 mg in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81952-111-0625 in 1 CARTON 06/12/2014
1NDC:81952-111-011 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
ANDA ANDA202957 06/12/2014
Heparin SodiumHeparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81952-115
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM(UNII: ZZ45AB24CA)
(HEPARIN - UNII:T2410KM04A) 		HEPARIN1000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81952-115-0725 in 1 CARTON 06/12/2014
1NDC:81952-115-022 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202732 06/12/2014
Heparin SodiumHeparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81952-114
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM(UNII: ZZ45AB24CA)
(HEPARIN - UNII:T2410KM04A) 		HEPARIN5000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)6 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)15 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81952-114-0925 in 1 CARTON 06/12/2014
1NDC:81952-114-0410 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
ANDA ANDA202733 06/12/2014

LABELER - Hepalink USA Inc.(079558168)

Establishment
Name Address ID/FEI Business Operations
Shenzhen Techdow Pharmaceutical Co., Ltd. 527809171 manufacture(81952-111, 81952-115, 81952-112, 81952-113, 81952-116, 81952-114), analysis(81952-111, 81952-115, 81952-112, 81952-113, 81952-116, 81952-114)

Establishment
Name Address ID/FEI Business Operations
Shenzhen Hepalink Pharmaceutical Group Co., Ltd. 547034665 api manufacture(81952-115, 81952-112, 81952-111, 81952-113, 81952-116, 81952-114)

PRINCIPAL DISPLAY PANEL

NDC 81952-111-01 Rx only

HEPARIN

SODIUM INJECTION, USP

5,000 USP Units/mL

NOT FOR LOCK FLUSH

For IV or SC use
Multiple Dose Vial

1 mL

heparin-fig1

PRINCIPAL DISPLAY PANEL


NDC 81952-111-06 Rx only

HEPARIN

SODIUM INJECTION, USP

5,000 USP Units/mL

NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials

1 mL

Derived from Porcine Intestinal Mucosa

heparin-fig2

PRINCIPAL DISPLAY PANEL

NDC 81952-115-02 Rx only

HEPARIN

SODIUM INJECTION, USP

2,000 USP Units/2mL

(1,000USP Units/mL)

NOT FOR LOCK FLUSH

For IV or SC use

Preservative Free

Discard unused portion

2mL Single Dose Vial

heparin-fig3

PRINCIPAL DISPLAY PANEL

NDC 81952-115-07 Rx only

HEPARIN

SODIUM INJECTION, USP

2,000 USP Units/2mL
(1,000USP Units/mL)
NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

Preservative Free

25 Single Dose Vials
2 mL

Derived from Porcine Intestinal Mucosa

heparin-fig4

PRINCIPAL DISPLAY PANEL

NDC 81952-112-01 Rx only

HEPARIN

SODIUM INJECTION, USP

1,000 USP Units/mL

NOT FOR LOCK FLUSH

For IV or SC use

Multiple Dose Vial

1mL

heparin-fig5

PRINCIPAL DISPLAY PANEL

NDC 81952-112-06 Rx only

HEPARIN

SODIUM INJECTION, USP

1,000 USP Units/mL

NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
1 mL

Derived from Porcine Intestinal Mucosa

heparin-fig6

PRINCIPAL DISPLAY PANEL

NDC 81952-112-04 Rx only

HEPARIN

SODIUM INJECTION, USP

10,000 USP Units/10mL
(1,000USP Units/mL)
NOT FOR LOCK FLUSH
For IV or SC use
Multiple Dose Vial

10mL

heparin-fig7

PRINCIPAL DISPLAY PANEL

NDC 81952-112-09 Rx only

HEPARIN

SODIUM INJECTION, USP

10,000 USP Units/10mL
(1,000USP Units/mL)


NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
10 mL

Derived from Porcine Intestinal Mucosa

heparin-fig 8

PRINCIPAL DISPLAY PANEL

NDC 81952-113-01 Rx only

HEPARIN

SODIUM INJECTION, USP

10,000 USP Units/mL

NOT FOR LOCK FLUSH

For IV or SC use

Multiple Dose Vial


1mL

heparin-fig9

PRINCIPAL DISPLAY PANEL

NDC 81952-113-06 Rx only

HEPARIN

SODIUM INJECTION, USP

10,000 USP Units/mL

NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
1 mL

Derived from Porcine Intestinal Mucosa

heparin-fig10

PRINCIPAL DISPLAY PANEL

NDC 81952-116-01 Rx only

HEPARIN

SODIUM INJECTION, USP

20,000 USP Units/mL

NOT FOR LOCK FLUSH

For IV or SC use

Multiple Dose Vial

1mL

heparin-fig11

PRINCIPAL DISPLAY PANEL

NDC 81952-116-06 Rx only

HEPARIN

SODIUM INJECTION, USP

20,000 USP Units/mL

NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
1 mL

Derived from Porcine Intestinal Mucosa

heparin-fig12

PRINCIPAL DISPLAY PANEL

NDC 81952-112-05 Rx only

HEPARIN

SODIUM INJECTION, USP

30,000 USP Units/30mL

(1,000 USP Units/mL)

NOT FOR LOCK FLUSH

For IV or SC use

Multiple Dose Vial

30mL

heparin-fig13

PRINCIPAL DISPLAY PANEL

NDC 81952-112-10 Rx only

HEPARIN

SODIUM INJECTION, USP

30,000 USP Units/30mL
(1,000USP Units/mL)


NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
30 mL

Derived from Porcine Intestinal Mucosa

heparin-fig14

PRINCIPAL DISPLAY PANEL

NDC 81952-113-03 Rx only

HEPARIN

SODIUM INJECTION, USP

50,000 USP Units/5mL
(10,000USP Units/mL)
NOT FOR LOCK FLUSH
For IV or SC use
Multiple Dose Vial


5mL

heparin-fig 15

PRINCIPAL DISPLAY PANEL

NDC 81952-113-08 Rx only

HEPARIN

SODIUM INJECTION, USP

50,000 USP Units/5mL
(10,000 USP Units/mL)


NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
5 mL

Derived from Porcine Intestinal Mucosa

heparin-fig16

PRINCIPAL DISPLAY PANEL

NDC 81952-114-04 Rx only

HEPARIN

SODIUM INJECTION, USP

50,000 USP Units/10mL

(5,000 USP Units/mL)

NOT FOR LOCK FLUSH

For IV or SC use

Multiple Dose Vial

10mL

heparin-fig17

PRINCIPAL DISPLAY PANEL

NDC 81952-114-09 Rx only

HEPARIN

SODIUM INJECTION, USP

50,000 USP Units/10mL
(5,000 USP Units/mL)


NOT FOR LOCK FLUSH

For Intravenous or Subcutaneous use

25 Multiple Dose Vials
10 mL

Derived from Porcine Intestinal Mucosa

heparin-fig18