PROCHLORPERAZINE MALEATE

Product NDC
42708-103
11-digit product format
427080103
Labeler code
42708
Product ID
42708-103_4682c28f-fee2-11c4-e063-6294a90a2342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine maleate
Dosage form
TABLET
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA040268
Marketing category
ANDA
Marketing start
1998-03-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-103-122021-03-15C16284748780-1ba0f9c33-5c5b-a910-e053-dadaa90a0b85PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only
42708-103-122021-01-29C16284748780-1ba0f9c33-5c5b-a910-e053-dadaa90a0b85PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-103-12PROCHLORPERAZINE MALEATE12 in 1 BOTTLETABLET126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-103PROCHLORPERAZINE MALEATE TABLET [QPHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20250521_dc692e77-5240-4aa6-8fe9-9ffcbb267261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSNdc692e77-5240-4aa6-8fe9-9ffcbb2672616
198365prochlorperazine 10 MG Oral TabletSCDdc692e77-5240-4aa6-8fe9-9ffcbb2672616
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYdc692e77-5240-4aa6-8fe9-9ffcbb2672616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-103-124270801031212 TABLET in 1 BOTTLE (42708-103-12) 12 tablet2019-10-180000-00-00YesNoCurrent