FDA.reportPublic FDA data

CHLORPROMAZINE HCI

Product NDC
43598-140
11-digit product format
435980140
Labeler code
43598
Product ID
43598-140_910baac6-1b03-7055-e946-0b4b1b1f043f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HCI
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Dr. Reddy's Laboratories Inc.,
Application
ANDA080365
Marketing category
ANDA
Marketing start
2024-09-04
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 HCI
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
43598-140-11CHLORPROMAZINE HCI1 mL in 1 VIALINJECTION14
43598-140-25CHLORPROMAZINE HCI25 in 1 CARTONINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-140-11ML - Milliliter43598-1402920a435-11ff-4f4c-8e30-8db0e44cc7e112024-09-09
43598-140-25ML - Milliliter43598-1407f75929e-03be-4f34-aae3-b9550ed7be6d12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-140CHLORPROMAZINE HCI INJECTION [DR. REDDY'S LABORATORIES INC.,]4Current NDC, 2 package rows20240926_1ec15bce-8a50-9c9a-419a-11b9d58dc5b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSN1ec15bce-8a50-9c9a-419a-11b9d58dc5b84
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSN1ec15bce-8a50-9c9a-419a-11b9d58dc5b84
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD1ec15bce-8a50-9c9a-419a-11b9d58dc5b84
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD1ec15bce-8a50-9c9a-419a-11b9d58dc5b84
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSY1ec15bce-8a50-9c9a-419a-11b9d58dc5b84
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSY1ec15bce-8a50-9c9a-419a-11b9d58dc5b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-140-11435980140111 mL in 1 VIAL1 mlHistorical
43598-140-254359801402525 VIAL in 1 CARTON (43598-140-25) / 1 mL in 1 VIAL (43598-140-11) 25 vial2024-09-04NoNoCurrent