FDA.reportPublic FDA data

prochlorperazine maleate

Product NDC
60219-2038
11-digit product format
602192038
Labeler code
60219
Product ID
60219-2038_64f464e7-2297-4543-a96d-bfe9e541930f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216598
Marketing category
ANDA
Marketing start
2023-04-21
Substance
PROCHLORPERAZINE MALEATE
Active strength
5 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
prochlorperazine maleate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1T8O1JTL6
Rxcui198365, 312635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-2038-1prochlorperazine maleate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
60219-2038-7prochlorperazine maleate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2038-1EA - Each60219-203851aafa7c-0a70-46c0-865b-97c04e37f57812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-2038PROCHLORPERAZINE MALEATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, 2 package rows20230421_a2a48790-0634-4b46-b362-98b7c252836f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSNa2a48790-0634-4b46-b362-98b7c252836f6
312635prochlorperazine maleate 5 MG Oral TabletPSNa2a48790-0634-4b46-b362-98b7c252836f6
198365prochlorperazine 10 MG Oral TabletSCDa2a48790-0634-4b46-b362-98b7c252836f6
312635prochlorperazine 5 MG Oral TabletSCDa2a48790-0634-4b46-b362-98b7c252836f6
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYa2a48790-0634-4b46-b362-98b7c252836f6
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSYa2a48790-0634-4b46-b362-98b7c252836f6
198365prochlorperazine maleate 10 MG Oral TabletPSN459fbfd6-f6fe-4589-894f-acd69b413de61
312635prochlorperazine maleate 5 MG Oral TabletPSN459fbfd6-f6fe-4589-894f-acd69b413de61
198365prochlorperazine 10 MG Oral TabletSCD459fbfd6-f6fe-4589-894f-acd69b413de61
312635prochlorperazine 5 MG Oral TabletSCD459fbfd6-f6fe-4589-894f-acd69b413de61
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY459fbfd6-f6fe-4589-894f-acd69b413de61
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY459fbfd6-f6fe-4589-894f-acd69b413de61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-2038-160219203801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-1) 2023-04-21NoNoHistorical
60219-2038-7602192038071000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-7) 2023-04-21NoNoHistorical