FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
50090-0491
11-digit product format
500900491
Labeler code
50090
Product ID
50090-0491_0e592d4b-25b6-42fe-8afa-4fa554e99a3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-03
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
5 mg/1
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000141

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
50090-0491-02023-02-06C16284748780-1f386c649-f630-0266-e053-dadaa90a7c1aMedroxyPROGESTERone Acetate Tablets, USP
50090-0491-12023-02-06C16284748780-1f386c649-f630-0266-e053-dadaa90a7c1aMedroxyPROGESTERone Acetate Tablets, USP
50090-0491-02023-01-30C16284748780-1f386c649-f630-0266-e053-dadaa90a7c1aMedroxyPROGESTERone Acetate Tablets, USP
50090-0491-12023-01-30C16284748780-1f386c649-f630-0266-e053-dadaa90a7c1aMedroxyPROGESTERone Acetate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0491-0Medroxyprogesterone Acetate10 in 1 BOTTLETABLET1013
50090-0491-1Medroxyprogesterone Acetate30 in 1 BOTTLETABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0491-1EA - Each50090-0491e91fbd37-3a62-4bd9-b489-36c50c7dfeeb12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0491MEDROXYPROGESTERONE ACETATE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20230207_bfdf335d-1cbb-4533-9fde-99a9c71f7504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNbfdf335d-1cbb-4533-9fde-99a9c71f750413
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDbfdf335d-1cbb-4533-9fde-99a9c71f750413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0491-05009004910010 TABLET in 1 BOTTLE (50090-0491-0) 10 tablet2019-01-170000-00-00NoNoCurrent
50090-0491-15009004910130 TABLET in 1 BOTTLE (50090-0491-1) 30 tablet2016-06-290000-00-00NoNoCurrent