FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
59651-570
11-digit product format
596510570
Labeler code
59651
Product ID
59651-570_22ddf306-4ee5-4358-900d-1e76b14bf237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216788
Marketing category
ANDA
Marketing start
2025-04-25
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorpromazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui991039, 991044, 991188, 991194, 991336

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
59651-570-01Chlorpromazine Hydrochloride100 in 1 BOTTLETABLET1003
59651-570-99Chlorpromazine Hydrochloride1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-570CHLORPROMAZINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20250507_c2a8b8a3-187f-4000-bde3-b40bb0e5600f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSNc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991044chlorproMAZINE HCl 100 MG Oral TabletPSNc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991188chlorproMAZINE HCl 200 MG Oral TabletPSNc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991194chlorproMAZINE HCl 25 MG Oral TabletPSNc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991336chlorproMAZINE HCl 50 MG Oral TabletPSNc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDc2a8b8a3-187f-4000-bde3-b40bb0e5600f3
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDc2a8b8a3-187f-4000-bde3-b40bb0e5600f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-570-0159651057001100 TABLET in 1 BOTTLE (59651-570-01) 100 tablet2025-04-25NoNoHistorical
59651-570-99596510570991000 TABLET in 1 BOTTLE (59651-570-99) 1000 tablet2025-04-25NoNoHistorical