Prochlorperazine Maleate

Product NDC
72603-169
11-digit product format
726030169
Labeler code
72603
Product ID
72603-169_2dda6392-975a-4d77-e063-6294a90a2f67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA216202
Marketing category
ANDA
Marketing start
2023-09-07
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, 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
72603-169-01Prochlorperazine Maleate100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-169PROCHLORPERAZINE MALEATE TABLET [NORTHSTAR RX LLC]4Current NDC, 1 package rows20250213_04bf8a16-218a-c648-e063-6294a90a1afb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN04bf8a16-218a-c648-e063-6294a90a1afb4
312635prochlorperazine maleate 5 MG Oral TabletPSN04bf8a16-218a-c648-e063-6294a90a1afb4
198365prochlorperazine 10 MG Oral TabletSCD04bf8a16-218a-c648-e063-6294a90a1afb4
312635prochlorperazine 5 MG Oral TabletSCD04bf8a16-218a-c648-e063-6294a90a1afb4
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY04bf8a16-218a-c648-e063-6294a90a1afb4
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY04bf8a16-218a-c648-e063-6294a90a1afb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-169-0172603016901100 TABLET in 1 BOTTLE (72603-169-01) 100 tablet2023-09-07NoNoHistorical