Prochlorperazine Maleate

Product NDC
70954-688
11-digit product format
709540688
Labeler code
70954
Product ID
70954-688_f884dbf6-01ce-4862-bb21-bf41cce2109a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
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
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 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
70954-688-10Prochlorperazine Maleate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-688-10EA - Each70954-688307a9d62-52d5-4c06-8f22-b6b696e23f9212022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-688PROCHLORPERAZINE MALEATE TABLET [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20250131_50ce4381-94ef-49ff-8794-cfde0ee803b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN50ce4381-94ef-49ff-8794-cfde0ee803b44
198365prochlorperazine maleate 10 MG Oral TabletPSNd6fc83ad-9cce-4e60-854c-3825313ee60c4
312635prochlorperazine maleate 5 MG Oral TabletPSN50ce4381-94ef-49ff-8794-cfde0ee803b44
312635prochlorperazine maleate 5 MG Oral TabletPSNd6fc83ad-9cce-4e60-854c-3825313ee60c4
198365prochlorperazine 10 MG Oral TabletSCD50ce4381-94ef-49ff-8794-cfde0ee803b44
198365prochlorperazine 10 MG Oral TabletSCDd6fc83ad-9cce-4e60-854c-3825313ee60c4
312635prochlorperazine 5 MG Oral TabletSCD50ce4381-94ef-49ff-8794-cfde0ee803b44
312635prochlorperazine 5 MG Oral TabletSCDd6fc83ad-9cce-4e60-854c-3825313ee60c4
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY50ce4381-94ef-49ff-8794-cfde0ee803b44
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYd6fc83ad-9cce-4e60-854c-3825313ee60c4
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY50ce4381-94ef-49ff-8794-cfde0ee803b44
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSYd6fc83ad-9cce-4e60-854c-3825313ee60c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-688-1070954068810100 TABLET in 1 BOTTLE (70954-688-10) 100 tablet2022-08-010000-00-00NoNoCurrent