Chlorpromazine hydrochloride

Product NDC
0641-1397
11-digit product format
006411397
Labeler code
0641
Product ID
0641-1397_5192ca14-ea80-4d18-9a66-2bcf7bfd094c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA083329
Marketing category
ANDA
Marketing start
1974-07-25
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-1397-31Chlorpromazine hydrochloride1 mL in 1 AMPULEINJECTION113
0641-1397-35Chlorpromazine hydrochloride25 in 1 CARTONINJECTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-1397-31ML - Milliliter0641-1397275f17e3-5cc2-43c4-a4f7-03ed477c418612012-07-24
0641-1397-35ML - Milliliter0641-1397bd64ef0c-307d-435d-99ed-3e675e95d3a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
CHLORPROMAZINEACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
CHLORPROMAZINEACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1397CHLORPROMAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20240410_c0f1fcfd-8863-4032-bf80-185df60a4ba0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSNc0f1fcfd-8863-4032-bf80-185df60a4ba013
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSNc0f1fcfd-8863-4032-bf80-185df60a4ba013
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDc0f1fcfd-8863-4032-bf80-185df60a4ba013
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDc0f1fcfd-8863-4032-bf80-185df60a4ba013
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSYc0f1fcfd-8863-4032-bf80-185df60a4ba013
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSYc0f1fcfd-8863-4032-bf80-185df60a4ba013
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSN310d161e-c4db-49e8-8665-d1a6d4e113206
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD310d161e-c4db-49e8-8665-d1a6d4e113206
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSY310d161e-c4db-49e8-8665-d1a6d4e113206
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSN0e97db69-e09b-407d-8a81-a36cc80fff132
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD0e97db69-e09b-407d-8a81-a36cc80fff132
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSY0e97db69-e09b-407d-8a81-a36cc80fff132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-1397-31006411397311 mL in 1 AMPULE1 mlHistorical
0641-1397-350064113973525 AMPULE in 1 CARTON (0641-1397-35) / 1 mL in 1 AMPULE (0641-1397-31) 25 ampule1974-07-250000-00-00NoNoCurrent