Prochlorperazine Maleate

Product NDC
0904-7381
11-digit product format
009047381
Labeler code
0904
Product ID
0904-7381_94b11ef8-b9c5-491f-a6ff-a3ec9e175ca0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA216202
Marketing category
ANDA
Marketing start
2022-08-01
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
0904-7381-06Prochlorperazine Maleate50 in 1 CARTONTABLET504
0904-7381-06Prochlorperazine Maleate1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7381-06EA - Each0904-7381855ffd38-d64f-46a9-a462-267e9df5977512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7381PROCHLORPERAZINE MALEATE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20250509_d6fc83ad-9cce-4e60-854c-3825313ee60c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSNd6fc83ad-9cce-4e60-854c-3825313ee60c4
312635prochlorperazine maleate 5 MG Oral TabletPSNd6fc83ad-9cce-4e60-854c-3825313ee60c4
198365prochlorperazine 10 MG Oral TabletSCDd6fc83ad-9cce-4e60-854c-3825313ee60c4
312635prochlorperazine 5 MG Oral TabletSCDd6fc83ad-9cce-4e60-854c-3825313ee60c4
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYd6fc83ad-9cce-4e60-854c-3825313ee60c4
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSYd6fc83ad-9cce-4e60-854c-3825313ee60c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7381-060090473810650 BLISTER PACK in 1 CARTON (0904-7381-06) / 1 TABLET in 1 BLISTER PACK50 blister pack2023-10-30NoNoHistorical