Prochlorperazine Maleate

Product NDC
60687-814
11-digit product format
606870814
Labeler code
60687
Product ID
60687-814_1b333ecf-b60b-8af8-e063-6394a90af538
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA216598
Marketing category
ANDA
Marketing start
2024-09-15
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
60687-814-11Prochlorperazine Maleate1 in 1 BLISTER PACKTABLET, FILM COATED11
60687-814-65Prochlorperazine Maleate50 in 1 CARTONTABLET, FILM COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-814-11EA - Each60687-814324179f9-05ee-426b-bb58-928f7493b90112024-10-04
60687-814-65EA - Each60687-814eda0b2cd-ecb1-4eb9-8af0-5b9d5f635c6412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-814PROCHLORPERAZINE MALEATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20240915_459fbfd6-f6fe-4589-894f-acd69b413de6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN459fbfd6-f6fe-4589-894f-acd69b413de61
312635prochlorperazine maleate 5 MG Oral TabletPSN459fbfd6-f6fe-4589-894f-acd69b413de61
198365prochlorperazine 10 MG Oral TabletSCD459fbfd6-f6fe-4589-894f-acd69b413de61
312635prochlorperazine 5 MG Oral TabletSCD459fbfd6-f6fe-4589-894f-acd69b413de61
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY459fbfd6-f6fe-4589-894f-acd69b413de61
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY459fbfd6-f6fe-4589-894f-acd69b413de61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-814-11606870814111 in 1 BLISTER PACKHistorical
60687-814-656068708146550 BLISTER PACK in 1 CARTON (60687-814-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-814-11) 50 blister pack2024-09-15NoNoHistorical