FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
64205-087
11-digit product format
642050087
Labeler code
64205
Product ID
64205-087_f127fece-11a0-457d-8653-763d471ff347
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
ReadyMeds
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-04
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
3 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
64205-087-302019-11-27C16284748780-19855e2a2-3b28-60a7-e053-dbdaa90a05bdMedroxyprogesterone Acetate Tablets USP
64205-087-902019-11-27C16284748780-19855e2a2-3b28-60a7-e053-dbdaa90a05bdMedroxyprogesterone Acetate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-087-30Medroxyprogesterone Acetate30 in 1 BOTTLETABLET308
64205-087-90Medroxyprogesterone Acetate90 in 1 BOTTLETABLET908

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-087MEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8Legacy NDC, 2 package rows20140506_ec517411-6d3d-4cb1-a50e-f0818d03b0e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCDec517411-6d3d-4cb1-a50e-f0818d03b0e48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-087-306420500873030 in 1 BOTTLEHistorical
64205-087-906420500879090 in 1 BOTTLEHistorical