FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
50090-0166
11-digit product format
500900166
Labeler code
50090
Product ID
50090-0166_af86bfa3-80a3-484e-8da7-517fa4f479bf
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
1996-12-04
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 mg/1
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000114

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
50090-0166-02023-02-07C16284748780-1f386c649-e513-0266-e053-dadaa90a7c1aMedroxyPROGESTERone Acetate Tablets, USP
50090-0166-22023-02-07C16284748780-1f386c649-e513-0266-e053-dadaa90a7c1aMedroxyPROGESTERone Acetate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0166-0Medroxyprogesterone Acetate10 in 1 BOTTLETABLET1017
50090-0166-2Medroxyprogesterone Acetate30 in 1 BOTTLETABLET3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0166-0EA - Each50090-01661d6a80fc-6faf-4046-b147-3b1d0b383f2e12018-08-13
50090-0166-2EA - Each50090-0166e3cdeb08-d03f-4710-a831-daefa4f6139b12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0166MEDROXYPROGESTERONE ACETATE TABLET [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20230306_816b9fd2-bc55-496b-846a-cabe7bbdecd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN816b9fd2-bc55-496b-846a-cabe7bbdecd617
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD816b9fd2-bc55-496b-846a-cabe7bbdecd617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0166-05009001660010 TABLET in 1 BOTTLE (50090-0166-0) 10 tablet2016-06-210000-00-00NoNoCurrent
50090-0166-25009001660230 TABLET in 1 BOTTLE (50090-0166-2) 30 tablet2014-11-280000-00-00NoNoCurrent