FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
69339-160
11-digit product format
693390160
Labeler code
69339
Product ID
69339-160_2de58bb1-eff3-471a-8760-7006d7c54030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA075671
Marketing category
ANDA
Marketing start
2023-07-31
Substance
MEGESTROL ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Megestrol Acetate
Listing expiration
2027-12-31

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69339-160-162025-07-29C16284748780-13b156c62-32f8-fb37-e063-e6dba90a4e07MEGESTROL ACETATE ORAL SUSPENSION, USP
69339-160-172025-07-29C16284748780-13b156c62-32f8-fb37-e063-e6dba90a4e07MEGESTROL ACETATE ORAL SUSPENSION, USP
69339-160-182025-07-29C16284748780-13b156c62-32f8-fb37-e063-e6dba90a4e07MEGESTROL ACETATE ORAL SUSPENSION, USP
69339-160-192025-07-29C16284748780-13b156c62-32f8-fb37-e063-e6dba90a4e07MEGESTROL ACETATE ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-160-01Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
69339-160-16Megestrol Acetate3 in 1 CASESUSPENSION32
69339-160-16Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-17Megestrol Acetate4 in 1 CASESUSPENSION42
69339-160-17Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-18Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-18Megestrol Acetate5 in 1 CASESUSPENSION52
69339-160-19Megestrol Acetate10 in 1 CASESUSPENSION102
69339-160-19Megestrol Acetate10 in 1 TRAYSUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-160-01ML - Milliliter69339-16067edb6da-5e2c-4fcc-8a4a-3b098aaff6eb12023-09-05
69339-160-16ML - Milliliter69339-16027f6e6c7-08d3-442e-b959-3a663f18545312023-09-05
69339-160-17ML - Milliliter69339-16031b3dcc7-2913-4c24-b3a6-640158ec6c3712023-09-05
69339-160-18ML - Milliliter69339-16059fcc138-63c5-45d5-b946-93f453f5505612023-09-05
69339-160-19ML - Milliliter69339-160da7e552a-6eec-4c7f-993b-b3d609d66d9912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-160MEGESTROL ACETATE SUSPENSION [NATCO PHARMA USA LLC]1Current NDC, 9 package rows20230825_582cff8a-1def-43d6-ba7e-dce49e3e9f27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 40 MG/ML Oral SuspensionSCD582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69339-160-016933901600110 mL in 1 CUP, UNIT-DOSE10 mlHistorical
69339-160-16693390160163 TRAY in 1 CASE (69339-160-16) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01) 3 tray2023-07-31NoNoHistorical
69339-160-17693390160174 TRAY in 1 CASE (69339-160-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01) 4 tray2023-07-31NoNoHistorical
69339-160-18693390160185 TRAY in 1 CASE (69339-160-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01) 5 tray2023-07-31NoNoHistorical
69339-160-196933901601910 TRAY in 1 CASE (69339-160-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01) 10 tray2023-07-31NoNoHistorical