FDA.reportPublic FDA data

CHLORPROMAZINE HYDROCHLORIDE

Product NDC
60687-452
11-digit product format
606870452
Labeler code
60687
Product ID
60687-452_4342f33e-4430-7a74-e063-6294a90adba7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209755
Marketing category
ANDA
Marketing start
2019-05-16
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
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
60687-452-01CHLORPROMAZINE HYDROCHLORIDE100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1005
60687-452-11CHLORPROMAZINE HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-452-01EA - Each60687-45228cc03ba-ad1e-445b-b0d6-b74f46f6aeaf12019-05-02
60687-452-11EA - Each60687-4524b77c32d-af02-4344-9b6e-ee0ae966f8a512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-452CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20240525_d43718e5-66d7-44f9-9fc8-80d38d3e41ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991044chlorproMAZINE HCl 100 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991188chlorproMAZINE HCl 200 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991194chlorproMAZINE HCl 25 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991336chlorproMAZINE HCl 50 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-452-0160687045201100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-452-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-452-11) 100 blister pack2019-05-160000-00-00NoNoCurrent
60687-452-11606870452111 in 1 BLISTER PACKHistorical