Megestrol Acetate

Product NDC
64380-158
11-digit product format
643800158
Labeler code
64380
Product ID
64380-158_0eff5604-5d6a-4e95-9a10-db18fb8046b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA072422
Marketing category
ANDA
Marketing start
2022-04-11
Substance
MEGESTROL ACETATE
Active strength
20 mg/1
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 ACETATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTJ2M0FR8ES
Rxcui860215, 860221

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
64380-158-01Megestrol Acetate100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-158-01EA - Each64380-158a5882026-48f6-4876-abe3-f1c46380a3c712022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-158MEGESTROL ACETATE TABLET [STRIDES PHARMA SCIENCE LIMITED]3Current NDC, Legacy NDC, 1 package rows20250226_8ec70070-da70-4a38-9d58-cf2278517661.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860215megestrol acetate 20 MG Oral TabletPSN8ec70070-da70-4a38-9d58-cf22785176613
860221megestrol acetate 40 MG Oral TabletPSN8ec70070-da70-4a38-9d58-cf22785176613
860215megestrol acetate 20 MG Oral TabletSCD8ec70070-da70-4a38-9d58-cf22785176613
860221megestrol acetate 40 MG Oral TabletSCD8ec70070-da70-4a38-9d58-cf22785176613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-158-0164380015801100 TABLET in 1 BOTTLE (64380-158-01) 100 tablet2022-04-110000-00-00NoNoCurrent