FDA.reportPublic FDA data

Pirfenidone

Product NDC
46708-479
11-digit product format
467080479
Labeler code
46708
Product ID
46708-479_5dd2966d-35b0-4a80-a677-bca6f4c69311
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pirfenidone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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, 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
46708-479-27Pirfenidone270 in 1 BOTTLETABLET, COATED2703
46708-479-64Pirfenidone3 in 1 CARTONTABLET, COATED33
46708-479-64Pirfenidone90 in 1 BOTTLETABLET, COATED903
46708-479-71Pirfenidone500 in 1 BOTTLETABLET, COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-479PIRFENIDONE TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, 4 package rows20230401_6e4f991a-c9e3-4121-97d0-d07954f17336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSN6e4f991a-c9e3-4121-97d0-d07954f173363
1868018pirfenidone 801 MG Oral TabletPSN6e4f991a-c9e3-4121-97d0-d07954f173363
1868014pirfenidone 267 MG Oral TabletSCD6e4f991a-c9e3-4121-97d0-d07954f173363
1868018pirfenidone 801 MG Oral TabletSCD6e4f991a-c9e3-4121-97d0-d07954f173363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-479-2746708047927270 TABLET, COATED in 1 BOTTLE (46708-479-27) 2022-11-22NoNoCurrent
46708-479-64467080479643 BOTTLE in 1 CARTON (46708-479-64) / 90 TABLET, COATED in 1 BOTTLE3 bottle2022-06-10NoNoCurrent
46708-479-7146708047971500 TABLET, COATED in 1 BOTTLE (46708-479-71) 2022-06-10NoNoCurrent