Chlorpromazine Hydrochloride

Product NDC
70771-1778
11-digit product format
707711778
Labeler code
70771
Product ID
70771-1778_bdfa9437-bd3f-496f-a640-753422d69c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Zydus Lifesciences Limited
Application
ANDA217275
Marketing category
ANDA
Marketing start
2024-03-29
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorpromazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui1730076, 1730078

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4907e598-fa92-6444-8b2a-22992506f30aProduct name720260202
78470689-2901-bec5-3fa3-182378bb1540Product name320250124
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1778-1Chlorpromazine Hydrochloride1 mL in 1 VIALINJECTION12
70771-1778-7Chlorpromazine Hydrochloride25 in 1 CARTONINJECTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1778CHLORPROMAZINE HYDROCHLORIDE INJECTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 2 package rows20240402_d37a4c21-b503-4791-a4d0-2ccc8891d88e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSNd37a4c21-b503-4791-a4d0-2ccc8891d88e2
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSNd37a4c21-b503-4791-a4d0-2ccc8891d88e2
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDd37a4c21-b503-4791-a4d0-2ccc8891d88e2
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDd37a4c21-b503-4791-a4d0-2ccc8891d88e2
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSYd37a4c21-b503-4791-a4d0-2ccc8891d88e2
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSYd37a4c21-b503-4791-a4d0-2ccc8891d88e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1778-1707711778011 mL in 1 VIAL1 mlHistorical
70771-1778-77077117780725 VIAL in 1 CARTON (70771-1778-7) / 1 mL in 1 VIAL (70771-1778-1) 25 vial2024-03-29NoNoCurrent