FDA.reportPublic FDA data

PIRFENIDONE

Product NDC
72205-182
11-digit product format
722050182
Labeler code
72205
Product ID
72205-182_2e84fe0d-424b-472b-938a-ef317ed61a79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIRFENIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212772
Marketing category
ANDA
Marketing start
2022-09-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-182-30PIRFENIDONE30 in 1 BOTTLETABLET, FILM COATED304
72205-182-36PIRFENIDONE3 in 1 CARTONTABLET, FILM COATED34
72205-182-90PIRFENIDONE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-182-30EA - Each72205-1827a867fe7-61e2-4bd8-b49f-95d8fe8634a812022-06-06
72205-182-36EA - Each72205-182aa0e7db0-c566-4118-8030-727de30a91a112022-06-06
72205-182-90EA - Each72205-1821374e0db-498b-489d-95d1-dcb401e9bbe112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-182PIRFENIDONE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 3 package rows20240724_741d1b9c-e281-4eca-b327-e25e82313006.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSN741d1b9c-e281-4eca-b327-e25e823130064
1868018pirfenidone 801 MG Oral TabletPSN741d1b9c-e281-4eca-b327-e25e823130064
1868014pirfenidone 267 MG Oral TabletSCD741d1b9c-e281-4eca-b327-e25e823130064
1868018pirfenidone 801 MG Oral TabletSCD741d1b9c-e281-4eca-b327-e25e823130064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-182-307220501823030 in 1 BOTTLEHistorical
72205-182-36722050182363 BOTTLE in 1 CARTON (72205-182-36) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-182-30) 3 bottle2022-09-080000-00-00NoNoCurrent
72205-182-907220501829090 TABLET, FILM COATED in 1 BOTTLE (72205-182-90) 2022-09-080000-00-00NoNoCurrent