PIRFENIDONE

Product NDC
69539-119
11-digit product format
695390119
Labeler code
69539
Product ID
69539-119_f5870f41-5199-4791-859f-530c43b41eb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIRFENIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA212772
Marketing category
ANDA
Marketing start
2022-05-24
Marketing end
0000-00-00
Substance
PIRFENIDONE
Active strength
267 mg/1
Pharmacologic classes
Pyridone [EPC], Pyridones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-119PIRFENIDONE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]5Legacy NDC20240724_a6c5ee89-ffb7-4eb1-a32c-e366981d2aac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-119-71695390119713 BOTTLE in 1 CARTON (69539-119-71) > 30 TABLET, FILM COATED in 1 BOTTLE (69539-119-30) 3 bottle2022-05-240000-00-00NoNoCurrent