FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
21695-896
11-digit product format
216950896
Labeler code
21695
Product ID
21695-896_44c1c923-ddcc-41b0-b710-bb61643593e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-08-09
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
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
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-896-102019-09-24C16284748780-1934fe258-4956-48b1-e053-8cdaa90a720aMEDROXYPROGESTERONE ACETATE TABLETS, USP
21695-896-202019-09-24C16284748780-1934fe258-4956-48b1-e053-8cdaa90a720aMEDROXYPROGESTERONE ACETATE TABLETS, USP
21695-896-302019-09-24C16284748780-1934fe258-4956-48b1-e053-8cdaa90a720aMEDROXYPROGESTERONE ACETATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-896-10Medroxyprogesterone Acetate10 in 1 BOTTLETABLET102
21695-896-20Medroxyprogesterone Acetate20 in 1 BOTTLETABLET202
21695-896-30Medroxyprogesterone Acetate30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-896-10EA - Each21695-896a7c42715-d006-4839-a13c-c366aa6cf41112012-07-24
21695-896-20EA - Each21695-89675fbf974-39a3-46ee-acd3-b86163f5d33f12012-07-24
21695-896-30EA - Each21695-89689a9a9cd-2a14-492f-9935-1b5a8fb4ff9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-896MEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 3 package rows20110907_e5f5c46c-b8b7-4502-9d2b-8f12284d1a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNe5f5c46c-b8b7-4502-9d2b-8f12284d1a632
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDe5f5c46c-b8b7-4502-9d2b-8f12284d1a632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-896-102169508961010 in 1 BOTTLEHistorical
21695-896-202169508962020 in 1 BOTTLEHistorical
21695-896-302169508963030 in 1 BOTTLEHistorical