FDA.reportPublic FDA data

Pirfenidone

Product NDC
62332-480
11-digit product format
623320480
Labeler code
62332
Product ID
62332-480_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
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
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
62332-480-71Pirfenidone500 in 1 BOTTLETABLET, COATED5009
62332-480-90Pirfenidone90 in 1 BOTTLETABLET, COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-480PIRFENIDONE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20231208_9214862e-9ef7-4370-856a-f5697978270a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868018pirfenidone 801 MG Oral TabletPSNbfcb3157-cfa1-493d-9598-1e7fd3d355d9101
1868018pirfenidone 801 MG Oral TabletSCDbfcb3157-cfa1-493d-9598-1e7fd3d355d9101
1868018pirfenidone 801 MG Oral TabletPSNbd3483bf-96e9-4d6b-a844-63bd002c48a4100
1868018pirfenidone 801 MG Oral TabletSCDbd3483bf-96e9-4d6b-a844-63bd002c48a4100
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-480-7162332048071500 TABLET, COATED in 1 BOTTLE (62332-480-71) 2022-06-100000-00-00NoNoCurrent
62332-480-906233204809090 TABLET, COATED in 1 BOTTLE (62332-480-90) 2022-06-100000-00-00NoNoCurrent