Megestrol Acetate

Product NDC
68094-174
11-digit product format
680940174
Labeler code
68094
Product ID
68094-174_1db455f2-43be-4c94-ab82-df6f226e26a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2022-07-11
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
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
68094-174-59Megestrol Acetate20 mL in 1 CUP, UNIT-DOSESUSPENSION202
68094-174-62Megestrol Acetate3 in 1 CASESUSPENSION32
68094-174-62Megestrol Acetate10 in 1 TRAYSUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-174-59ML - Milliliter68094-174c0a8ddb9-b1b2-46fc-8732-fd5937e55d2912022-09-12
68094-174-62ML - Milliliter68094-1744b36204b-d8a4-49c9-9504-420407e21b8912022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-174MEGESTROL ACETATE SUSPENSION [PRECISION DOSE INC.]2Current NDC, Legacy NDC, 3 package rows20240404_bf0d54c5-b813-4f2e-9a37-cbea332cfe53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 40 MG/ML Oral SuspensionSCDbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYbf0d54c5-b813-4f2e-9a37-cbea332cfe532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-174-596809401745920 mL in 1 CUP, UNIT-DOSE20 mlHistorical
68094-174-62680940174623 TRAY in 1 CASE (68094-174-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (68094-174-59) 3 tray2022-07-110000-00-00NoNoCurrent