FDA.reportPublic FDA data

Pirfenidone

Product NDC
76282-716
11-digit product format
762820716
Labeler code
76282
Product ID
76282-716_3449172d-fe07-4924-ad05-89b854600aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pirfenidone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS INC.
Application
ANDA212078
Marketing category
ANDA
Marketing start
2022-08-02
Substance
PIRFENIDONE
Active strength
801 mg/1
Pharmacologic classes
Pyridone [EPC], Pyridones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pirfenidone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIRFENIDONE801 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7NLD2JX7U
Rxcui1868014, 1868018

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
82ab2cd4-4ada-41b1-950d-75fef25f7bacProduct name320250818
d62f4d7c-9247-4aa4-ad93-12349422d49eProduct name220240530
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-716-27Pirfenidone270 in 1 BOTTLETABLET, COATED2702
76282-716-90Pirfenidone90 in 1 BOTTLETABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-716PIRFENIDONE TABLET, COATED [EXELAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20220811_c171e4af-1619-4712-958f-ef96adfede37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSNc171e4af-1619-4712-958f-ef96adfede372
1868018pirfenidone 801 MG Oral TabletPSNc171e4af-1619-4712-958f-ef96adfede372
1868014pirfenidone 267 MG Oral TabletSCDc171e4af-1619-4712-958f-ef96adfede372
1868018pirfenidone 801 MG Oral TabletSCDc171e4af-1619-4712-958f-ef96adfede372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-716-2776282071627270 TABLET, COATED in 1 BOTTLE (76282-716-27) 2022-08-020000-00-00NoNoCurrent
76282-716-907628207169090 TABLET, COATED in 1 BOTTLE (76282-716-90) 2022-08-020000-00-00NoNoCurrent