FDA.reportPublic FDA data

ChlorproMAZINE Hydrochloride

Product NDC
90096-132
11-digit product format
900960132
Labeler code
90096
Product ID
90096-132_2a02dff9-bd37-438d-bac9-ec0fb6faaf09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ChlorproMAZINE Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Zameer Pharmaceuticals LLC
Application
ANDA212630
Marketing category
ANDA
Marketing start
2022-02-05
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 mg/1
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/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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90096-132-012024-02-13C16284748780-11030e365-1a9e-111a-e063-dadaa90a10e2ChlorproMAZINE Hydrochloride Tablets, USP Rx only
90096-132-012024-01-30C16284748780-11030e365-1a9e-111a-e063-dadaa90a10e2ChlorproMAZINE Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90096-132-01ChlorproMAZINE Hydrochloride100 in 1 BOTTLETABLET, SUGAR COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90096-132CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [ZAMEER PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20241222_da3c2935-817d-4331-83c3-ed68ba5d35fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSNda3c2935-817d-4331-83c3-ed68ba5d35fd3
991044chlorproMAZINE HCl 100 MG Oral TabletPSNda3c2935-817d-4331-83c3-ed68ba5d35fd3
991188chlorproMAZINE HCl 200 MG Oral TabletPSNda3c2935-817d-4331-83c3-ed68ba5d35fd3
991194chlorproMAZINE HCl 25 MG Oral TabletPSNda3c2935-817d-4331-83c3-ed68ba5d35fd3
991336chlorproMAZINE HCl 50 MG Oral TabletPSNda3c2935-817d-4331-83c3-ed68ba5d35fd3
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDda3c2935-817d-4331-83c3-ed68ba5d35fd3
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDda3c2935-817d-4331-83c3-ed68ba5d35fd3
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDda3c2935-817d-4331-83c3-ed68ba5d35fd3
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDda3c2935-817d-4331-83c3-ed68ba5d35fd3
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDda3c2935-817d-4331-83c3-ed68ba5d35fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
90096-132-0190096013201100 TABLET, SUGAR COATED in 1 BOTTLE (90096-132-01) 2022-02-050000-00-00NoNoCurrent