FDA.reportPublic FDA data

Pirfenidone

Product NDC
62332-479
11-digit product format
623320479
Labeler code
62332
Product ID
62332-479_9f41a23e-cc34-4b25-871d-deeef997fe8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pirfenidone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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
62332-479-27Pirfenidone270 in 1 BOTTLETABLET, COATED2709
62332-479-64Pirfenidone3 in 1 CARTONTABLET, COATED39
62332-479-64Pirfenidone90 in 1 BOTTLETABLET, COATED909
62332-479-71Pirfenidone500 in 1 BOTTLETABLET, COATED5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-479-64EA - Each62332-47950c0790d-131d-4b89-8ea9-440e9277457f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-479PIRFENIDONE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 4 package rows20231208_9214862e-9ef7-4370-856a-f5697978270a.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
1868014pirfenidone 267 MG Oral TabletPSN33f1ca21-4c08-4103-889d-1d9c929b5fad100
1868014pirfenidone 267 MG Oral TabletSCD33f1ca21-4c08-4103-889d-1d9c929b5fad100
1868014pirfenidone 267 MG Oral TabletPSN9214862e-9ef7-4370-856a-f5697978270a9
1868018pirfenidone 801 MG Oral TabletPSN9214862e-9ef7-4370-856a-f5697978270a9
1868014pirfenidone 267 MG Oral TabletSCD9214862e-9ef7-4370-856a-f5697978270a9
1868018pirfenidone 801 MG Oral TabletSCD9214862e-9ef7-4370-856a-f5697978270a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-479-2762332047927270 TABLET, COATED in 1 BOTTLE (62332-479-27) 2022-11-22NoNoHistorical
62332-479-64623320479643 BOTTLE in 1 CARTON (62332-479-64) / 90 TABLET, COATED in 1 BOTTLE3 bottle2022-06-100000-00-00NoNoCurrent
62332-479-7162332047971500 TABLET, COATED in 1 BOTTLE (62332-479-71) 2022-06-100000-00-00NoNoCurrent