FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
69452-472
11-digit product format
694520472
Labeler code
69452
Product ID
69452-472_2cf363d6-b9e5-2c22-e063-6394a90a7649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217478
Marketing category
ANDA
Marketing start
2025-01-31
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
69452-472-20PROCHLORPERAZINE MALEATE100 in 1 BOTTLETABLET1001
69452-472-32PROCHLORPERAZINE MALEATE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-472-20EA - Each69452-47224d5ce6e-dc33-466e-96f1-2025c324fefa12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-472PROCHLORPERAZINE MALEATE TABLET [BIONPHARMA INC.]1Current NDC, 2 package rows20250202_2cf363d6-b9e4-2c22-e063-6394a90a7649.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN44f278eb-3588-af83-e063-6394a90a73cf2
198365prochlorperazine 10 MG Oral TabletSCD44f278eb-3588-af83-e063-6394a90a73cf2
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY44f278eb-3588-af83-e063-6394a90a73cf2
198365prochlorperazine maleate 10 MG Oral TabletPSN2cf363d6-b9e4-2c22-e063-6394a90a76491
312635prochlorperazine maleate 5 MG Oral TabletPSN2cf363d6-b9e4-2c22-e063-6394a90a76491
198365prochlorperazine 10 MG Oral TabletSCD2cf363d6-b9e4-2c22-e063-6394a90a76491
312635prochlorperazine 5 MG Oral TabletSCD2cf363d6-b9e4-2c22-e063-6394a90a76491
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY2cf363d6-b9e4-2c22-e063-6394a90a76491
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY2cf363d6-b9e4-2c22-e063-6394a90a76491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-472-2069452047220100 TABLET in 1 BOTTLE (69452-472-20) 100 tablet2025-01-31NoNoCurrent
69452-472-32694520472321000 TABLET in 1 BOTTLE (69452-472-32) 1000 tablet2025-01-31NoNoCurrent