FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
70518-3510
11-digit product format
705183510
Labeler code
70518
Product ID
70518-3510_4f1f5a23-122c-16e0-e063-6294a90a6d6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214827
Marketing category
ANDA
Marketing start
2022-09-06
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui991194

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
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3510-0Chlorpromazine Hydrochloride30 in 1 BLISTER PACKTABLET, SUGAR COATED307
70518-3510-1Chlorpromazine Hydrochloride100 in 1 BOXTABLET, SUGAR COATED1007
70518-3510-2Chlorpromazine Hydrochloride1 in 1 POUCHTABLET, SUGAR COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3510CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 3 package rows20240420_2122d619-3f5b-48f6-8f0b-7693199abbdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991194chlorproMAZINE HCl 25 MG Oral TabletPSN2122d619-3f5b-48f6-8f0b-7693199abbdb7
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD2122d619-3f5b-48f6-8f0b-7693199abbdb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3510-07051835100030 TABLET, SUGAR COATED in 1 BLISTER PACK (70518-3510-0) 2022-09-060000-00-00NoNoCurrent
70518-3510-170518351001100 in 1 BOXHistorical
70518-3510-2705183510021 in 1 POUCHHistorical