FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
51407-910
11-digit product format
514070910
Labeler code
51407
Product ID
51407-910_19c32f0a-07d6-26c2-e063-6294a90a49e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2001-07-25
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
078c5235-b5d8-c448-12aa-7c7688d21da3Product name320180205
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
51407-910-24Megestrol Acetate240 mL in 1 BOTTLE, PLASTICSUSPENSION2401
51407-910-48Megestrol Acetate480 mL in 1 BOTTLE, PLASTICSUSPENSION4801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-910-24ML - Milliliter51407-910c8a047ba-48d3-4728-accd-00041c973dfe12024-07-12
51407-910-48ML - Milliliter51407-910ba38ab36-5e8d-4c04-a870-c1ad2f82accf12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-910MEGESTROL ACETATE SUSPENSION [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20240602_19c33213-7919-208d-e063-6394a90a0f08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 40 MG/ML Oral SuspensionSCD19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY19c33213-7919-208d-e063-6394a90a0f081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-910-2451407091024240 mL in 1 BOTTLE, PLASTIC (51407-910-24) 240 ml2024-04-22NoNoCurrent
51407-910-4851407091048480 mL in 1 BOTTLE, PLASTIC (51407-910-48) 480 ml2024-04-22NoNoCurrent