Megestrol Acetate

Product NDC
68788-8714
11-digit product format
687888714
Labeler code
68788
Product ID
68788-8714_06743d22-d4e5-4543-9b01-e33febeba791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2024-07-12
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEGESTROL ACETATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTJ2M0FR8ES

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
68788-8714-2Megestrol Acetate240 mL in 1 BOTTLE, PLASTICSUSPENSION2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8714-2ML - Milliliter68788-871465c7339f-fa9b-4d54-95f0-24cb4d24b4d812024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8714MEGESTROL ACETATE SUSPENSION [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20240727_edef65d1-d583-4cee-bb9a-515be84ac51d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 40 MG/ML Oral SuspensionSCDedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYedef65d1-d583-4cee-bb9a-515be84ac51d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8714-268788871402240 mL in 1 BOTTLE, PLASTIC (68788-8714-2) 240 ml2024-07-12NoNoCurrent