Prochlorperazine Maleate

Product NDC
70518-4200
11-digit product format
705184200
Labeler code
70518
Product ID
70518-4200_3ff4e764-1554-cca9-e063-6294a90accb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216495
Marketing category
ANDA
Marketing start
2024-10-02
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
70518-4200-0Prochlorperazine Maleate10 in 1 BOTTLE, PLASTICTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4200PROCHLORPERAZINE MALEATE TABLET [REMEDYREPACK INC.]5Current NDC, 1 package rows20241213_5c1dd0ea-89e9-4317-a83e-5e15da79ca20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN5c1dd0ea-89e9-4317-a83e-5e15da79ca206
198365prochlorperazine 10 MG Oral TabletSCD5c1dd0ea-89e9-4317-a83e-5e15da79ca206
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY5c1dd0ea-89e9-4317-a83e-5e15da79ca206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4200-07051842000010 TABLET in 1 BOTTLE, PLASTIC (70518-4200-0) 10 tablet2024-10-02NoNoHistorical