FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
60687-916
11-digit product format
606870916
Labeler code
60687
Product ID
60687-916_47a6376f-18d0-c130-e063-6394a90a918d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077404
Marketing category
ANDA
Marketing start
2026-01-05
Substance
MEGESTROL ACETATE
Active strength
40 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 ACETATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTJ2M0FR8ES
Rxcui860225

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
078c5235-b5d8-c448-12aa-7c7688d21da3Product name320180205
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
1bec0d29-4d8b-21df-403d-4848e3aaa3bcProduct name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-916-08Megestrol Acetate3 in 1 CASESUSPENSION32
60687-916-42Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
60687-916-48Megestrol Acetate10 in 1 TRAYSUSPENSION102
60687-916-56Megestrol Acetate10 in 1 CASESUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-916-08ML - Milliliter60687-916d4265852-b654-455b-b097-6dce3f91f01012026-01-08
60687-916-42ML - Milliliter60687-916c85b7c47-1d3d-437d-85f0-0db23ac4e79612026-01-08
60687-916-56ML - Milliliter60687-9165716dd30-4ef6-4c85-bb02-0014871e63c512026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 40 MG/ML Oral SuspensionSCD2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY2921731a-6866-4dc8-8f6b-b636abf7bcf82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-916-08606870916083 TRAY in 1 CASE (60687-916-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-916-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-916-42) 3 tray2026-01-05NoNoHistorical
60687-916-426068709164210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-916-486068709164810 in 1 TRAYHistorical
60687-916-566068709165610 TRAY in 1 CASE (60687-916-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-916-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-916-42) 10 tray2026-01-05NoNoHistorical