FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
70954-896
11-digit product format
709540896
Labeler code
70954
Product ID
70954-896_a26dcd78-ad62-4cf5-ad97-49ccb34d43ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA077404
Marketing category
ANDA
Marketing start
2024-07-02
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
078c5235-b5d8-c448-12aa-7c7688d21da3Product name320180205
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
70954-896-10Megestrol Acetate240 mL in 1 BOTTLESUSPENSION2401
70954-896-20Megestrol Acetate480 mL in 1 BOTTLESUSPENSION4801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-896-10ML - Milliliter70954-896db521f1c-3702-4f32-a294-4bcf215d917612024-08-12
70954-896-20ML - Milliliter70954-89601dc1ce3-792f-450e-aec3-50b90ee7437a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-896MEGESTROL ACETATE SUSPENSION [ANI PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240712_a26dcd78-ad62-4cf5-ad97-49ccb34d43ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 40 MG/ML Oral SuspensionSCD2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY2d5b58cd-cbb1-4f5c-b13f-63185c0f8e313
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 40 MG/ML Oral SuspensionSCD2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 40 MG/ML Oral SuspensionSCDe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYe44cf173-991b-43cf-93f2-e0efaa4cc29a2
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY2921731a-6866-4dc8-8f6b-b636abf7bcf82
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSNa26dcd78-ad62-4cf5-ad97-49ccb34d43ba1
860225megestrol acetate 40 MG/ML Oral SuspensionSCDa26dcd78-ad62-4cf5-ad97-49ccb34d43ba1
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSYa26dcd78-ad62-4cf5-ad97-49ccb34d43ba1
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSYa26dcd78-ad62-4cf5-ad97-49ccb34d43ba1
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSYa26dcd78-ad62-4cf5-ad97-49ccb34d43ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-896-1070954089610240 mL in 1 BOTTLE (70954-896-10) 240 ml2024-07-02NoNoHistorical
70954-896-2070954089620480 mL in 1 BOTTLE (70954-896-20) 480 ml2024-07-02NoNoHistorical