FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
68071-4132
11-digit product format
680714132
Labeler code
68071
Product ID
68071-4132_1a1433a6-8d05-96df-e063-6394a90a987b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
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 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
68071-4132-12024-06-04C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-32024-06-04C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-12023-01-30C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-32023-01-30C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-12021-02-12C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-32021-02-12C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-12021-01-29C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP
68071-4132-32021-01-29C16284748780-1ba0f9c33-2fa0-a910-e053-dadaa90a0b85MedroxyPROGESTERone Acetate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4132-1Medroxyprogesterone Acetate10 in 1 BOTTLETABLET106
68071-4132-3Medroxyprogesterone Acetate30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4132MEDROXYPROGESTERONE ACETATE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 2 package rows20240606_5c8ffae3-3b3e-197e-e053-2a91aa0a59e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN5c8ffae3-3b3e-197e-e053-2a91aa0a59e36
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD5c8ffae3-3b3e-197e-e053-2a91aa0a59e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4132-16807141320110 TABLET in 1 BOTTLE (68071-4132-1) 10 tablet2017-10-270000-00-00NoNoCurrent
68071-4132-36807141320330 TABLET in 1 BOTTLE (68071-4132-3) 30 tablet2017-10-270000-00-00NoNoCurrent