FDA.reportPublic FDA data

CHLORPROMAZINE HYDROCHLORIDE

Product NDC
69238-1054
11-digit product format
692381054
Labeler code
69238
Product ID
69238-1054_9e50c657-1fae-40c2-af7e-e3c389dd5a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209755
Marketing category
ANDA
Marketing start
2018-09-12
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
69238-1054-1CHLORPROMAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1054-1EA - Each69238-10544c57f430-2e52-4fd9-9c37-ad6c413a92a712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1054CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 1 package rows20231230_aa086a21-de85-4b03-af58-49b70acf8cf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991044chlorproMAZINE HCl 100 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991188chlorproMAZINE HCl 200 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991194chlorproMAZINE HCl 25 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991336chlorproMAZINE HCl 50 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991039chlorproMAZINE HCl 10 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991044chlorproMAZINE HCl 100 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991188chlorproMAZINE HCl 200 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991194chlorproMAZINE HCl 25 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991336chlorproMAZINE HCl 50 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991039chlorpromazine hydrochloride 10 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991188chlorpromazine hydrochloride 200 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991336chlorpromazine hydrochloride 50 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1054-169238105401100 TABLET, FILM COATED in 1 BOTTLE (69238-1054-1) 2018-09-120000-00-00NoNoCurrent