PROCHLORPERAZINE MALEATE

Product NDC
21695-571
11-digit product format
216950571
Labeler code
21695
Product ID
21695-571_a49905cc-dd53-43a2-8113-d8ada3f8cae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040268
Marketing category
ANDA
Marketing start
1998-03-01
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE MALEATE
Active strength
5 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
21695-571-302019-09-24C16284748780-1934fe258-4ab8-48b1-e053-8cdaa90a720aPROCHLORPERAZINE MALEATE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-571-30PROCHLORPERAZINE MALEATE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-571-30EA - Each21695-5711a72ddf3-6821-4e4b-8b82-10f841892bb112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Prochlorperazine MaleateACTIVE INGREDIENTI1T8O1JTL6PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
ProchlorperazineACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Fd&c Blue No. 2INACTIVE INGREDIENTL06K8R7DQKPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1APROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-571PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110121_a49905cc-dd53-43a2-8113-d8ada3f8cae9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSNa49905cc-dd53-43a2-8113-d8ada3f8cae91
312635prochlorperazine maleate 5 MG Oral TabletPSNa49905cc-dd53-43a2-8113-d8ada3f8cae91
198365prochlorperazine 10 MG Oral TabletSCDa49905cc-dd53-43a2-8113-d8ada3f8cae91
312635prochlorperazine 5 MG Oral TabletSCDa49905cc-dd53-43a2-8113-d8ada3f8cae91
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYa49905cc-dd53-43a2-8113-d8ada3f8cae91
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSYa49905cc-dd53-43a2-8113-d8ada3f8cae91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-571-302169505713030 in 1 BOTTLEHistorical