Prochlorperazine Maleate

Product NDC
27241-286
11-digit product format
272410286
Labeler code
27241
Product ID
27241-286_7f4898d9-da1a-4966-885d-c5e350bcb1dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA218515
Marketing category
ANDA
Marketing start
2024-05-09
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
27241-286-01Prochlorperazine Maleate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-286-01EA - Each27241-28636277d97-99a0-4b91-bbc0-fcc59f31763f12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-286PROCHLORPERAZINE MALEATE TABLET [AJANTA PHARMA USA INC.]3Current NDC, 1 package rows20241127_9ab78746-b302-4836-95f3-343799929c0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN9ab78746-b302-4836-95f3-343799929c0e4
312635prochlorperazine maleate 5 MG Oral TabletPSN9ab78746-b302-4836-95f3-343799929c0e4
198365prochlorperazine 10 MG Oral TabletSCD9ab78746-b302-4836-95f3-343799929c0e4
312635prochlorperazine 5 MG Oral TabletSCD9ab78746-b302-4836-95f3-343799929c0e4
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY9ab78746-b302-4836-95f3-343799929c0e4
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY9ab78746-b302-4836-95f3-343799929c0e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-286-0127241028601100 TABLET in 1 BOTTLE (27241-286-01) 100 tablet2024-05-09NoNoHistorical