FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
81033-150
11-digit product format
810330150
Labeler code
81033
Product ID
81033-150_3dd3d565-dc60-0c31-e063-6394a90a46e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA075671
Marketing category
ANDA
Marketing start
2025-08-07
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

Additional Listing Data#

Finished product
Yes
Brand name base
Megestrol Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEGESTROL ACETATE40 mg/mL

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-150-10Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
81033-150-20Megestrol Acetate20 mL in 1 CUP, UNIT-DOSESUSPENSION202
81033-150-43Megestrol Acetate30 in 1 CARTONSUSPENSION302
81033-150-44Megestrol Acetate40 in 1 CARTONSUSPENSION402
81033-150-52Megestrol Acetate100 in 1 CASESUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-150-10ML - Milliliter81033-1502543ec6f-320f-47bb-88e6-1bd5a4fa284b12025-10-14
81033-150-20ML - Milliliter81033-1509e74f5d4-302f-4a2d-a129-9a357e7aca5712025-10-14
81033-150-43ML - Milliliter81033-150279d1fc3-9aa7-4b9b-937a-b401452542c012025-10-14
81033-150-44ML - Milliliter81033-1509e40ce0b-f969-42d9-bcec-d288997ecd7a12025-10-14
81033-150-52ML - Milliliter81033-1502736f854-8353-4dde-8304-cfebdc4cac3912025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 40 MG/ML Oral SuspensionSCD3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY3bc8708e-a52d-fda2-e063-6294a90a0fbc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-150-108103301501010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
81033-150-208103301502020 mL in 1 CUP, UNIT-DOSE20 mlHistorical
81033-150-438103301504330 CUP, UNIT-DOSE in 1 CARTON (81033-150-43) / 20 mL in 1 CUP, UNIT-DOSE (81033-150-20) 2025-08-07NoNoCurrent
81033-150-448103301504440 CUP, UNIT-DOSE in 1 CARTON (81033-150-44) / 10 mL in 1 CUP, UNIT-DOSE (81033-150-10) 2025-08-07NoNoCurrent
81033-150-5281033015052100 CUP, UNIT-DOSE in 1 CASE (81033-150-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-150-10) 2025-08-07NoNoCurrent