FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
24979-041
11-digit product format
249790041
Labeler code
24979
Product ID
24979-041_85b17cc1-0b8d-47a1-9d00-597920cdb7b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA203139
Marketing category
ANDA
Marketing start
2015-03-01
Substance
MEGESTROL ACETATE
Active strength
125 mg/mL
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 ACETATE125 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTJ2M0FR8ES
Rxcui577154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
078c5235-b5d8-c448-12aa-7c7688d21da3Product name320180205
1bec0d29-4d8b-21df-403d-4848e3aaa3bcProduct name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24979-041-132023-02-02C16284748780-1f386c649-b0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEGESTROL ACETATE ORAL SUSPENSION safely and effectively. See full prescribing information for MEGESTROL ACETATE ORAL SUSPENSION. MEGESTROL ACETATE oral suspension Initial U.S. Approval: 1993
24979-041-132023-02-02C16284748780-1f386c649-b0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEGESTROL ACETATE ORAL SUSPENSION safely and effectively. See full prescribing information for MEGESTROL ACETATE ORAL SUSPENSION. MEGESTROL ACETATE oral suspension Initial U.S. Approval: 1993
24979-041-132023-01-30C16284748780-1f386c649-b0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEGESTROL ACETATE ORAL SUSPENSION safely and effectively. See full prescribing information for MEGESTROL ACETATE ORAL SUSPENSION. MEGESTROL ACETATE oral suspension Initial U.S. Approval: 1993
24979-041-132023-01-30C16284748780-1f386c649-b0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEGESTROL ACETATE ORAL SUSPENSION safely and effectively. See full prescribing information for MEGESTROL ACETATE ORAL SUSPENSION. MEGESTROL ACETATE oral suspension Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-041-13Megestrol Acetate150 mL in 1 BOTTLESUSPENSION15019
24979-041-35Megestrol Acetate35 mL in 1 BOTTLESUSPENSION3519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-041-13ML - Milliliter24979-041b1b8132c-0fca-475e-8da7-9480e675aada12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEGESTROL ACETATEACTIVE INGREDIENTTJ2M0FR8ESMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
MEGESTROLACTIVE MOIETYEA6LD1M70MMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-041MEGESTROL ACETATE SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]15Current NDC, Legacy NDC, 2 package rows20250326_2dc921d5-e423-4379-a345-151e87d13651.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577154megestrol acetate 625 MG in 5 mL Oral SuspensionPSN2dc921d5-e423-4379-a345-151e87d1365119
577154megestrol acetate 125 MG/ML Oral SuspensionSCD2dc921d5-e423-4379-a345-151e87d1365119
577154megestrol acetate 625 MG per 5 ML Oral SuspensionSY2dc921d5-e423-4379-a345-151e87d1365119
577154megestrol acetate 625 MG in 5 mL Oral SuspensionPSN6342df31-afce-4deb-b992-e08e2a4b2b772
577154megestrol acetate 125 MG/ML Oral SuspensionSCD6342df31-afce-4deb-b992-e08e2a4b2b772
577154megestrol acetate 625 MG per 5 ML Oral SuspensionSY6342df31-afce-4deb-b992-e08e2a4b2b772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24979-041-1324979004113150 mL in 1 BOTTLE (24979-041-13) 150 ml2015-07-280000-00-00NoNoCurrent
24979-041-352497900413535 mL in 1 BOTTLE (24979-041-35) 35 ml2025-12-01NoNoHistorical