FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
64380-160
11-digit product format
643800160
Labeler code
64380
Product ID
64380-160_d842f1ed-8df5-4fe9-a694-5da7a042134e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-160-01Megestrol Acetate240 mL in 1 BOTTLE, PLASTICSUSPENSION2404
64380-160-02Megestrol Acetate480 mL in 1 BOTTLE, PLASTICSUSPENSION4804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-160-01ML - Milliliter64380-160ae478ac5-15ea-47c9-badf-adac50a39c9612022-05-04
64380-160-02ML - Milliliter64380-160041c014a-1a03-4b30-aba2-d1f0ea79c22d12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-160MEGESTROL ACETATE SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]4Current NDC, Legacy NDC, 2 package rows20220423_9f7365a0-67cf-45fc-a914-e40a4507a063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN9f7365a0-67cf-45fc-a914-e40a4507a0634
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN46622697-2c51-44d5-9f1f-e48f8526f1324
860225megestrol acetate 40 MG/ML Oral SuspensionSCD9f7365a0-67cf-45fc-a914-e40a4507a0634
860225megestrol acetate 40 MG/ML Oral SuspensionSCD46622697-2c51-44d5-9f1f-e48f8526f1324
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY9f7365a0-67cf-45fc-a914-e40a4507a0634
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY46622697-2c51-44d5-9f1f-e48f8526f1324
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY9f7365a0-67cf-45fc-a914-e40a4507a0634
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY46622697-2c51-44d5-9f1f-e48f8526f1324
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY9f7365a0-67cf-45fc-a914-e40a4507a0634
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY46622697-2c51-44d5-9f1f-e48f8526f1324
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
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNd0ad931e-4e3e-48bf-9949-77d6971da6e62
860225megestrol acetate 40 MG/ML Oral SuspensionSCD3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 40 MG/ML Oral SuspensionSCDd0ad931e-4e3e-48bf-9949-77d6971da6e62
860225megestrol acetate 40 MG/ML Oral SuspensionSCDbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 40 MG/ML Oral SuspensionSCD582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 40 MG/ML Oral SuspensionSCDedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYd0ad931e-4e3e-48bf-9949-77d6971da6e62
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYd0ad931e-4e3e-48bf-9949-77d6971da6e62
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYedef65d1-d583-4cee-bb9a-515be84ac51d2
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYd0ad931e-4e3e-48bf-9949-77d6971da6e62
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYbf0d54c5-b813-4f2e-9a37-cbea332cfe532
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY3bc8708e-a52d-fda2-e063-6294a90a0fbc2
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 40 MG/ML Oral SuspensionSCD19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY19c33213-7919-208d-e063-6394a90a0f081
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY19c33213-7919-208d-e063-6394a90a0f081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-160-0164380016001240 mL in 1 BOTTLE, PLASTIC (64380-160-01) 240 ml2022-03-210000-00-00NoNoCurrent
64380-160-0264380016002480 mL in 1 BOTTLE, PLASTIC (64380-160-02) 480 ml2022-03-210000-00-00NoNoCurrent