Prochlorperazine Maleate

Product NDC
82868-044
11-digit product format
828680044
Labeler code
82868
Product ID
82868-044_47a70b0b-9e78-e333-e063-6394a90a6bd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA216495
Marketing category
ANDA
Marketing start
2024-02-06
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prochlorperazine Maleate
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82868-044-30Prochlorperazine Maleate30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-044PROCHLORPERAZINE MALEATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240220_115a4125-07df-9f9b-e063-6394a90a3e49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN115a4125-07df-9f9b-e063-6394a90a3e493
198365prochlorperazine 10 MG Oral TabletSCD115a4125-07df-9f9b-e063-6394a90a3e493
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY115a4125-07df-9f9b-e063-6394a90a3e493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-044-308286800443030 TABLET in 1 BOTTLE, PLASTIC (82868-044-30) 30 tablet2024-02-06NoNoCurrent