FDA.reportPublic FDA data

PIRFENIDONE

Product NDC
16729-467
11-digit product format
167290467
Labeler code
16729
Product ID
16729-467_462905a9-67d0-513b-e063-6294a90aa9b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIRFENIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA212730
Marketing category
ANDA
Marketing start
2022-05-27
Substance
PIRFENIDONE
Active strength
267 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
PIRFENIDONE267 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
16729-467-15PIRFENIDONE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
16729-467-64PIRFENIDONE270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2709
16729-467-85PIRFENIDONE3 in 1 CARTONTABLET, FILM COATED39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-467-15EA - Each16729-46745d28e3d-49f8-47b7-8c8d-5d9bfe4a515b12022-06-06
16729-467-85EA - Each16729-467ca37516b-83df-4d6f-801f-0ebe29dd63d612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-467PIRFENIDONE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]7Current NDC, Legacy NDC, 3 package rows20241006_fab59395-1c5d-4c64-ba47-34d75736e983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSNfab59395-1c5d-4c64-ba47-34d75736e9839
1868018pirfenidone 801 MG Oral TabletPSNfab59395-1c5d-4c64-ba47-34d75736e9839
1868014pirfenidone 267 MG Oral TabletSCDfab59395-1c5d-4c64-ba47-34d75736e9839
1868018pirfenidone 801 MG Oral TabletSCDfab59395-1c5d-4c64-ba47-34d75736e9839

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-467-151672904671590 in 1 BOTTLE, PLASTICHistorical
16729-467-6416729046764270 in 1 BOTTLE, PLASTICHistorical
16729-467-85167290467853 BOTTLE, PLASTIC in 1 CARTON (16729-467-85) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-467-15) 2022-05-270000-00-00NoNoCurrent