Chlorpromazine Hydrochloride

Product NDC
70518-4294
11-digit product format
705184294
Labeler code
70518
Product ID
70518-4294_401ccac6-a5d6-bf76-e063-6294a90a87f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA084114
Marketing category
ANDA
Marketing start
2025-02-26
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui991044

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
70518-4294-0Chlorpromazine Hydrochloride100 in 1 BOXTABLET, FILM COATED1003
70518-4294-1Chlorpromazine Hydrochloride1 in 1 POUCHTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4294CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 2 package rows20250228_9709ffde-7034-42be-97be-f5f39eeacf72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991044chlorproMAZINE HCl 100 MG Oral TabletPSN9709ffde-7034-42be-97be-f5f39eeacf723
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD9709ffde-7034-42be-97be-f5f39eeacf723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4294-070518429400100 POUCH in 1 BOX (70518-4294-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4294-1) 100 pouch2025-02-26NoNoCurrent
70518-4294-1705184294011 in 1 POUCHHistorical