FDA.reportPublic FDA data

Megestrol Acetate

Product NDC
49884-907
11-digit product format
498840907
Labeler code
49884
Product ID
49884-907_ec56e3fd-9c8b-4999-a9fe-3f28d1a10ecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2001-07-25
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-907-38ML - Milliliter49884-907f021309a-c675-4b48-a4e7-fd0f01a0175d12012-07-24
49884-907-61ML - Milliliter49884-907b9a1ff97-6008-4a7c-b940-9170440ba7b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
megestrol acetateACTIVE INGREDIENTTJ2M0FR8ESMEGESTROL ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
megestrolACTIVE MOIETYEA6LD1M70MMEGESTROL ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554MEGESTROL ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KMEGESTROL ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMEGESTROL ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEMEGESTROL ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN160b602d-07bd-46fc-93fe-f89300c6b62f1
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN3c02f4fb-2d1f-3529-e054-00144ff88e881
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN904d8eef-194c-4802-9fe0-a4ac999b50021
860225megestrol acetate 40 MG/ML Oral SuspensionSCD160b602d-07bd-46fc-93fe-f89300c6b62f1
860225megestrol acetate 40 MG/ML Oral SuspensionSCD3c02f4fb-2d1f-3529-e054-00144ff88e881
860225megestrol acetate 40 MG/ML Oral SuspensionSCD904d8eef-194c-4802-9fe0-a4ac999b50021
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY160b602d-07bd-46fc-93fe-f89300c6b62f1
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY3c02f4fb-2d1f-3529-e054-00144ff88e881
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY904d8eef-194c-4802-9fe0-a4ac999b50021
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY160b602d-07bd-46fc-93fe-f89300c6b62f1
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY3c02f4fb-2d1f-3529-e054-00144ff88e881
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY904d8eef-194c-4802-9fe0-a4ac999b50021
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY160b602d-07bd-46fc-93fe-f89300c6b62f1
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY3c02f4fb-2d1f-3529-e054-00144ff88e881
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY904d8eef-194c-4802-9fe0-a4ac999b50021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-907-3849884090738240 mL in 1 BOTTLE, PLASTIC (49884-907-38) 240 ml2001-07-252024-11-30NoNoCurrent
49884-907-6149884090761480 mL in 1 BOTTLE, PLASTIC (49884-907-61) 480 ml2001-07-252024-12-31NoNoCurrent