Megestrol Acetate

Product NDC
0555-0607
11-digit product format
005550607
Labeler code
0555
Product ID
0555-0607_6f22887e-a442-4505-bd99-00042e4075c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074621
Marketing category
ANDA
Marketing start
1995-11-30
Substance
MEGESTROL ACETATE
Active strength
40 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 ACETATE40 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
0555-0607-02Megestrol Acetate100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0607-02EA - Each0555-0607a11adede-d92f-4882-8273-bf73c794be2c12013-02-13
0555-0607-04EA - Each0555-06076c559447-57ba-402c-82d1-efa74aae2da812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEGESTROL ACETATEACTIVE INGREDIENTTJ2M0FR8ESMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
MEGESTROLACTIVE MOIETYEA6LD1M70MMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0607MEGESTROL ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 1 package rows20250119_66573d39-f2a7-49fd-9ed2-97ac8f6e8456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860215megestrol acetate 20 MG Oral TabletPSN66573d39-f2a7-49fd-9ed2-97ac8f6e845612
860221megestrol acetate 40 MG Oral TabletPSN66573d39-f2a7-49fd-9ed2-97ac8f6e845612
860215megestrol acetate 20 MG Oral TabletSCD66573d39-f2a7-49fd-9ed2-97ac8f6e845612
860221megestrol acetate 40 MG Oral TabletSCD66573d39-f2a7-49fd-9ed2-97ac8f6e845612
860221megestrol acetate 40 MG Oral TabletPSN9b764cf3-4756-4f0e-b747-421d716743131
860221megestrol acetate 40 MG Oral TabletSCD9b764cf3-4756-4f0e-b747-421d716743131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0607-0200555060702100 TABLET in 1 BOTTLE (0555-0607-02) 100 tablet1995-11-300000-00-00NoNoCurrent