CHLORPROMAZINE HYDROCHLORIDE- chlorpromazine hydrochloride injection 
Zydus Lifesciences Limited

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Chlorpromazine Hydrochloride Injection, USP

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1778-1

chlorproMAZINE Hydrochloride Injection, USP

25 mg/mL

For Deep Intramuscular Use

Discard unused portion

1 mL Single-Dose Vial

Rx only

25 mg/ml

NDC 70771-1778-7

chlorproMAZINE Hydrochloride Injection, USP

25 mg/mL

For Deep Intramuscular Use

Discard unused portion

25 x 1 mL Single-Dose Vial

Rx only

25mg/ml
CHLORPROMAZINE HYDROCHLORIDE 
chlorpromazine hydrochloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1779
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1779-725 in 1 CARTON03/29/2024
1NDC:70771-1779-12 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21727503/29/2024
CHLORPROMAZINE HYDROCHLORIDE 
chlorpromazine hydrochloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1778
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1778-725 in 1 CARTON03/29/2024
1NDC:70771-1778-11 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21727503/29/2024
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1778, 70771-1779) , ANALYSIS(70771-1778, 70771-1779)

Revised: 3/2024
Document Id: bcbd52b5-2981-407b-b260-0568efab3890
Set id: d37a4c21-b503-4791-a4d0-2ccc8891d88e
Version: 1
Effective Time: 20240314
 
Zydus Lifesciences Limited