FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
0121-1038
11-digit product format
001211038
Labeler code
0121
Product ID
0121-1038_5dbcf915-968f-4377-b56f-8ef863e398ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA077404
Marketing category
ANDA
Marketing start
2025-10-17
Substance
MEGESTROL ACETATE
Active strength
400 mg/10mL
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
Megestrol Acetate
Listing expiration
2026-12-31

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
0121-1038-00Megestrol Acetate10 in 1 TRAYSUSPENSION103
0121-1038-00Megestrol Acetate10 in 1 CASESUSPENSION103
0121-1038-10Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION103
0121-1038-40Megestrol Acetate10 in 1 TRAYSUSPENSION103
0121-1038-40Megestrol Acetate4 in 1 CASESUSPENSION43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1038-00ML - Milliliter0121-103831d060ca-0025-4007-95cc-160258c5a07c12025-11-13
0121-1038-10ML - Milliliter0121-10383a83e12b-6df1-4a6a-83c8-ba43fc57374712025-11-13
0121-1038-40ML - Milliliter0121-103871f219f7-e714-4fd4-89ae-c817d8c937f412025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 40 MG/ML Oral SuspensionSCD2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1038-000012110380010 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10) 10 tray2025-10-17NoNoHistorical
0121-1038-100012110381010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0121-1038-40001211038404 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10) 4 tray2025-10-17NoNoHistorical