FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
0116-4011
11-digit product format
001164011
Labeler code
0116
Product ID
0116-4011_3aae2aec-a959-8e66-e063-6294a90a8f46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA076721
Marketing category
ANDA
Marketing start
2025-03-28
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-4011-08Megestrol Acetate237 mL in 1 BOTTLE, PLASTICSUSPENSION2372
0116-4011-10Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
0116-4011-11Megestrol Acetate10 in 1 TRAYSUSPENSION102
0116-4011-11Megestrol Acetate10 in 1 CASESUSPENSION102
0116-4011-16Megestrol Acetate480 mL in 1 BOTTLE, PLASTICSUSPENSION4802
0116-4011-30Megestrol Acetate10 in 1 TRAYSUSPENSION102
0116-4011-30Megestrol Acetate30 in 1 CASESUSPENSION302
0116-4011-40Megestrol Acetate10 in 1 TRAYSUSPENSION102
0116-4011-40Megestrol Acetate40 in 1 CASESUSPENSION402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-4011MEGESTROL ACETATE SUSPENSION [XTTRIUM LABORATORIES, INC.]1Current NDC, 9 package rows20250503_3169f883-4076-32ce-e063-6394a90a4925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN3169f883-4076-32ce-e063-6394a90a49252
860225megestrol acetate 40 MG/ML Oral SuspensionSCD3169f883-4076-32ce-e063-6394a90a49252
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY3169f883-4076-32ce-e063-6394a90a49252
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY3169f883-4076-32ce-e063-6394a90a49252
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY3169f883-4076-32ce-e063-6394a90a49252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0116-4011-0800116401108237 mL in 1 BOTTLE, PLASTIC (0116-4011-08) 237 ml2025-03-28NoNoHistorical
0116-4011-100011640111010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0116-4011-110011640111110 TRAY in 1 CASE (0116-4011-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10) 10 tray2025-03-28NoNoHistorical
0116-4011-1600116401116480 mL in 1 BOTTLE, PLASTIC (0116-4011-16) 480 ml2025-03-28NoNoHistorical
0116-4011-300011640113030 TRAY in 1 CASE (0116-4011-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10) 30 tray2025-03-28NoNoHistorical
0116-4011-400011640114040 TRAY in 1 CASE (0116-4011-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10) 40 tray2025-03-28NoNoHistorical