Prochlorperazine Maleate

Product NDC
72189-503
11-digit product format
721890503
Labeler code
72189
Product ID
72189-503_2c4e4a5c-f12a-8c46-e063-6394a90ae95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040268
Marketing category
ANDA
Marketing start
2023-08-03
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 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
Prochlorperazine Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1T8O1JTL6
Rxcui198365

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
72189-503-30Prochlorperazine Maleate30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-503-30EA - Each72189-5035e4674a5-ed45-4f21-8363-b3931c3fd37c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-503PROCHLORPERAZINE MALEATE TABLET [DIRECT_RX]2Current NDC, 1 package rows20250123_02069e43-5245-20dc-e063-6294a90a9dcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN02069e43-5245-20dc-e063-6294a90a9dcd2
198365prochlorperazine 10 MG Oral TabletSCD02069e43-5245-20dc-e063-6294a90a9dcd2
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY02069e43-5245-20dc-e063-6294a90a9dcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-503-307218905033030 TABLET in 1 BOTTLE (72189-503-30) 30 tablet2023-08-03NoNoHistorical