Prochlorperazine Maleate

Product NDC
62135-674
11-digit product format
621350674
Labeler code
62135
Product ID
62135-674_164e1b55-c60e-98fa-e063-6294a90abcdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040101
Marketing category
ANDA
Marketing start
1996-07-19
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, 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
62135-674-90Prochlorperazine Maleate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-674-90EA - Each62135-67497a6fc5e-c96a-4c52-aba0-58f88864e30e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-674PROCHLORPERAZINE MALEATE TABLET, FILM COATED [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240418_91adec24-fac8-4a56-b2c3-ae4bbc1160bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN91adec24-fac8-4a56-b2c3-ae4bbc1160bf1
312635prochlorperazine maleate 5 MG Oral TabletPSN91adec24-fac8-4a56-b2c3-ae4bbc1160bf1
198365prochlorperazine 10 MG Oral TabletSCD91adec24-fac8-4a56-b2c3-ae4bbc1160bf1
312635prochlorperazine 5 MG Oral TabletSCD91adec24-fac8-4a56-b2c3-ae4bbc1160bf1
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY91adec24-fac8-4a56-b2c3-ae4bbc1160bf1
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY91adec24-fac8-4a56-b2c3-ae4bbc1160bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-674-906213506749090 TABLET, FILM COATED in 1 BOTTLE (62135-674-90) 2024-03-25NoNoHistorical