PROCHLORPERAZINE MALEATE

Product NDC
10544-281
11-digit product format
105440281
Labeler code
10544
Product ID
10544-281_0ff320ac-60f4-4b75-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040268
Marketing category
ANDA
Marketing start
2013-11-18
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-281-302020-01-31C16284748780-19d75b9d0-47fe-f424-e053-dadaa90a57cePROCHLORPERAZINE MALEATE TABLETS USP Rx Only
10544-281-602020-01-31C16284748780-19d75b9d0-47fe-f424-e053-dadaa90a57cePROCHLORPERAZINE MALEATE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-281-30PROCHLORPERAZINE MALEATE30 in 1 BOTTLETABLET301
10544-281-60PROCHLORPERAZINE MALEATE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-281-30EA - Each10544-281471857c7-8a0b-45e1-a64e-a4842f1b548b12015-05-05
10544-281-60EA - Each10544-281c249616d-1a88-4926-93b6-894f05de36ad12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCHLORPERAZINE MALEATEACTIVE INGREDIENTI1T8O1JTL6PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-281PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20150226_0ff320ac-60f3-4b75-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN0ff320ac-60f3-4b75-e054-00144ff88e881
312635prochlorperazine maleate 5 MG Oral TabletPSN0ff320ac-60f3-4b75-e054-00144ff88e881
198365prochlorperazine 10 MG Oral TabletSCD0ff320ac-60f3-4b75-e054-00144ff88e881
312635prochlorperazine 5 MG Oral TabletSCD0ff320ac-60f3-4b75-e054-00144ff88e881
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY0ff320ac-60f3-4b75-e054-00144ff88e881
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY0ff320ac-60f3-4b75-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-281-301054402813030 in 1 BOTTLEHistorical
10544-281-601054402816060 in 1 BOTTLEHistorical