FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
17856-0060
11-digit product format
178560060
Labeler code
17856
Product ID
17856-0060_35ced36e-d65c-4dca-e063-6294a90ae85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2022-03-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0060-32024-05-09C16284748780-11030e365-29a0-111a-e063-dadaa90a10e2MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-42024-05-09C16284748780-11030e365-29a0-111a-e063-dadaa90a10e2MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-32024-01-30C16284748780-11030e365-29a0-111a-e063-dadaa90a10e2MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-42024-01-30C16284748780-11030e365-29a0-111a-e063-dadaa90a10e2MEGESTROL ACETATE ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0060-1Megestrol Acetate10 mL in 1 CUPSUSPENSION103
17856-0060-2Megestrol Acetate20 mL in 1 CUPSUSPENSION203
17856-0060-3Megestrol Acetate72 in 1 BOXSUSPENSION723
17856-0060-4Megestrol Acetate50 in 1 BOXSUSPENSION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0060MEGESTROL ACETATE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]3Current NDC, Legacy NDC, 4 package rows20250524_01119031-9943-4afb-8b45-cb71682f0482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN01119031-9943-4afb-8b45-cb71682f04823
860225megestrol acetate 40 MG/ML Oral SuspensionSCD01119031-9943-4afb-8b45-cb71682f04823
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY01119031-9943-4afb-8b45-cb71682f04823
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY01119031-9943-4afb-8b45-cb71682f04823
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY01119031-9943-4afb-8b45-cb71682f04823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0060-11785600600110 mL in 1 CUP10 mlHistorical
17856-0060-21785600600220 mL in 1 CUP20 mlHistorical
17856-0060-31785600600372 CUP in 1 BOX (17856-0060-3) / 10 mL in 1 CUP (17856-0060-1) 72 cup2024-05-090000-00-00NoNoCurrent
17856-0060-41785600600450 CUP in 1 BOX (17856-0060-4) / 20 mL in 1 CUP (17856-0060-2) 50 cup2024-05-090000-00-00NoNoCurrent