Medroxyprogesterone Acetate

Product NDC
68788-8112
11-digit product format
687888112
Labeler code
68788
Product ID
68788-8112_eb5a5d6e-84fd-445b-ae1f-e339a2054632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040159
Marketing category
ANDA
Marketing start
2021-12-06
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

Related Records

Active Ingredients

IngredientStrength
MEDROXYPROGESTERONE ACETATE5 mg/1

Harmonized Identifiers

FieldValues
UniiC2QI4IOI2G
Rxcui1000141

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
C2QI4IOI2GMEDROXYPROGESTERONE ACETATE71-58-9MEDROXYPROGESTERONE ACETATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8112-36878881120330 TABLET in 1 BOTTLE (68788-8112-3) 30 tablet2021-12-060000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MedroxyPROGESTERone Acetate Tablets, USPPreferred Pharmaceuticals Inc.2025-08-05HUMAN PRESCRIPTION DRUG LABEL5