NDC Code(s) : 0641-1397-31, 0641-1397-35, 0641-1398-31, 0641-1398-35
Packager : Hikma Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chlorpromazine hydrochlorideChlorpromazine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-1397
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE(UNII: 9WP59609J6)
(CHLORPROMAZINE - UNII:U42B7VYA4P) 		CHLORPROMAZINE HYDROCHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)2 mg in 1 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)1 mg in 1 mL
SODIUM SULFITE(UNII: VTK01UQK3G)1 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)6 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-1397-3525 in 1 CARTON 25/07/1974
1NDC:0641-1397-311 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083329 07/25/1974
Chlorpromazine hydrochlorideChlorpromazine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-1398
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE(UNII: 9WP59609J6)
(CHLORPROMAZINE - UNII:U42B7VYA4P) 		CHLORPROMAZINE HYDROCHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)2 mg in 1 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)1 mg in 1 mL
SODIUM SULFITE(UNII: VTK01UQK3G)1 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)6 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-1398-3525 in 1 CARTON 25/07/1974
1NDC:0641-1398-312 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083329 07/25/1974

LABELER - Hikma Pharmaceuticals USA Inc.(946499746)

Establishment
Name Address ID/FEI Business Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A 452742943 analysis(0641-1397, 0641-1398), label(0641-1397, 0641-1398), manufacture(0641-1397, 0641-1398), pack(0641-1397, 0641-1398)

PRINCIPAL DISPLAY PANEL

NDC 0641-1397-31 Rx only

chlorproMAZINE HCl Injection, USP

25 mg/mL

For deep IM use

Protect from light

1 mL Ampul

1 mL ampul

NDC 0641-1397-35   Rx only

chlorproMAZINE

HCl Injection, USP

25 mg/mL

For deep Intramuscular use

25 x 1 mL Ampuls

1 mL ampul

PRINCIPAL DISPLAY PANEL

NDC 0641-1398-31 Rx only

chlorproMAZINE HCl Injection, USP

50 mg per 2 mL (25 mg/mL)

For deep IM use

Protect from light

2 mL Ampul

2 mL ampul

NDC 0641-1398-35 Rx only

chlorproMAZINE

HCl Injection, USP

50 mg per 2 mL (25 mg/mL)

For deep Intramuscular use

25 x 2 mL Ampuls

2 mL ampul

PRINCIPAL DISPLAY PANEL

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