Megestrol Acetate

Product NDC
50383-859
11-digit product format
503830859
Labeler code
50383
Product ID
50383-859_b8a13616-2b5c-469c-a85c-11c881e8c8d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Akorn
Application
ANDA203960
Marketing category
ANDA
Marketing start
2017-04-10
Marketing end
0000-00-00
Substance
MEGESTROL ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-859-10ML - Milliliter50383-859e9f5e5b6-5c0e-42aa-b333-bc16efddf90f12017-12-14
50383-859-11ML - Milliliter50383-859ce0e1a65-5e80-488c-a319-3547fe760f0a12017-12-14
50383-859-12ML - Milliliter50383-8592725475b-8bfc-49ec-82d7-88710252d9dc12017-12-14
50383-859-24ML - Milliliter50383-859821bacbf-8707-48b7-961a-16ab3df853e112017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-859MEGESTROL ACETATE SUSPENSION [AKORN]12Legacy NDC20220920_7f7676cd-469b-450b-b064-339b84d4047f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-859-11503830859114 TRAY in 1 CASE (50383-859-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10) 4 tray2017-06-090000-00-00NoNoCurrent
50383-859-125038308591210 TRAY in 1 CASE (50383-859-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10) 10 tray2017-06-090000-00-00NoNoCurrent
50383-859-21503830859214 TRAY in 1 CASE (50383-859-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-859-20) 4 tray2017-06-090000-00-00NoNoCurrent
50383-859-225038308592210 TRAY in 1 CASE (50383-859-22) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-859-20) 10 tray2017-06-090000-00-00NoNoCurrent
50383-859-24503830859241 BOTTLE in 1 CARTON (50383-859-24) > 240 mL in 1 BOTTLE1 bottle2017-06-090000-00-00NoNoCurrent