FDA.reportPublic FDA data

Pirfenidone

Product NDC
72162-2465
11-digit product format
721622465
Labeler code
72162
Product ID
72162-2465_83800d33-deb2-4159-8a64-8758f9f5aac7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pirfenidone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212708
Marketing category
ANDA
Marketing start
2022-06-10
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

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
72162-2465-2Pirfenidone90 in 1 BOTTLETABLET, COATED90105
72162-2465-2Pirfenidone3 in 1 CARTONTABLET, COATED3105
72162-2465-4Pirfenidone270 in 1 BOTTLETABLET, COATED270105
72162-2465-9Pirfenidone90 in 1 BOTTLETABLET, COATED90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2465-2EA - Each72162-2465646cd3cc-5a64-4463-9e8b-af14b918e22d12025-05-14
72162-2465-4EA - Each72162-246572cc5163-fbbc-4d77-bc5f-c209103f72dd12025-06-13
72162-2465-9EA - Each72162-246510736fba-f6e4-4480-a28c-3ea4e1662b6612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2465PIRFENIDONE TABLET, COATED [BRYANT RANCH PREPACK]103Current NDC, 4 package rows20250521_9bdc7ed9-e51c-4101-a792-31619f05136b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSN9bdc7ed9-e51c-4101-a792-31619f05136b105
1868014pirfenidone 267 MG Oral TabletSCD9bdc7ed9-e51c-4101-a792-31619f05136b105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2465-2721622465023 BOTTLE in 1 CARTON (72162-2465-2) / 90 TABLET, COATED in 1 BOTTLE3 bottle2025-03-06NoNoCurrent
72162-2465-472162246504270 TABLET, COATED in 1 BOTTLE (72162-2465-4) 2025-05-14NoNoCurrent
72162-2465-97216224650990 TABLET, COATED in 1 BOTTLE (72162-2465-9) 2025-05-14NoNoCurrent