Megestrol Acetate

Product NDC
68788-8714
11-digit product format
687888714
Labeler code
68788
Product ID
68788-8714_06743d22-d4e5-4543-9b01-e33febeba791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2024-07-12
Substance
MEGESTROL ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
TJ2M0FR8ESMEGESTROL ACETATE595-33-5MEGESTROL ACETATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8714-268788871402240 mL in 1 BOTTLE, PLASTIC (68788-8714-2) 240 ml2024-07-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MEGESTROL ACETATE ORAL SUSPENSION, USPPreferred Pharmaceuticals Inc.2025-08-05HUMAN PRESCRIPTION DRUG LABEL2