FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
0904-7577
11-digit product format
009047577
Labeler code
0904
Product ID
0904-7577_1843fe79-7628-4f8e-9b51-e0be7562e43d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077404
Marketing category
ANDA
Marketing start
2025-12-29
Substance
MEGESTROL ACETATE
Active strength
400 mg/10mL
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
Megestrol Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEGESTROL ACETATE400 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTJ2M0FR8ES
Rxcui860225

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
078c5235-b5d8-c448-12aa-7c7688d21da3Product name320180205
1bec0d29-4d8b-21df-403d-4848e3aaa3bcProduct name220170725
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7577-18Megestrol Acetate4 in 1 CASESUSPENSION42
0904-7577-18Megestrol Acetate10 in 1 TRAYSUSPENSION102
0904-7577-66Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
0904-7577-72Megestrol Acetate10 in 1 TRAYSUSPENSION102
0904-7577-72Megestrol Acetate10 in 1 CASESUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7577-18ML - Milliliter0904-7577428b9fa4-ee7e-4a59-b922-17074597758712026-02-05
0904-7577-66ML - Milliliter0904-757791989707-c7e8-4371-8dda-fec52a69876812026-02-05
0904-7577-72ML - Milliliter0904-7577a5a455d8-6bba-44fb-864c-5fa3173e1f3812026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 40 MG/ML Oral SuspensionSCDe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYe44cf173-991b-43cf-93f2-e0efaa4cc29a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7577-18009047577184 TRAY in 1 CASE (0904-7577-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66) 4 tray2026-01-15NoNoHistorical
0904-7577-660090475776610 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0904-7577-720090475777210 TRAY in 1 CASE (0904-7577-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66) 10 tray2025-12-29NoNoHistorical