Medroxyprogesterone Acetate

Product NDC
53002-3570
11-digit product format
530023570
Labeler code
53002
Product ID
53002-3570_ee170f0d-4dd7-4e01-bf75-848337c6fc66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-04
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3570-1Medroxyprogesterone Acetate10 in 1 BOTTLETABLET106
53002-3570-3Medroxyprogesterone Acetate30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3570MEDROXYPROGESTERONE ACETATE TABLET [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20230609_ceccfb43-ad89-482d-9564-5867df1c936f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNceccfb43-ad89-482d-9564-5867df1c936f6
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDceccfb43-ad89-482d-9564-5867df1c936f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3570-15300235700110 TABLET in 1 BOTTLE (53002-3570-1) 10 tablet2018-10-020000-00-00NoNoCurrent
53002-3570-35300235700330 TABLET in 1 BOTTLE (53002-3570-3) 30 tablet2018-10-020000-00-00NoNoCurrent