FDA.reportPublic FDA data

Pirfenidone

Product NDC
70954-869
11-digit product format
709540869
Labeler code
70954
Product ID
70954-869_fd354df5-de31-47d3-a67b-a45ad121153e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pirfenidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA212722
Marketing category
ANDA
Marketing start
2022-07-19
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
70954-869-10Pirfenidone3 in 1 CARTONTABLET, FILM COATED36
70954-869-10Pirfenidone90 in 1 BOTTLETABLET, FILM COATED906
70954-869-30Pirfenidone270 in 1 BOTTLETABLET, FILM COATED2706

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-869-30EA - Each70954-86947e0c408-406f-45f0-aa12-14011bb0af1d12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-869PIRFENIDONE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]5Current NDC, 3 package rows20250511_976620bb-c10e-4b13-8a97-7025fda6b7d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSN976620bb-c10e-4b13-8a97-7025fda6b7d56
1868018pirfenidone 801 MG Oral TabletPSN976620bb-c10e-4b13-8a97-7025fda6b7d56
1868014pirfenidone 267 MG Oral TabletSCD976620bb-c10e-4b13-8a97-7025fda6b7d56
1868018pirfenidone 801 MG Oral TabletSCD976620bb-c10e-4b13-8a97-7025fda6b7d56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-869-10709540869103 BOTTLE in 1 CARTON (70954-869-10) / 90 TABLET, FILM COATED in 1 BOTTLE3 bottle2022-07-19NoNoCurrent
70954-869-3070954086930270 TABLET, FILM COATED in 1 BOTTLE (70954-869-30) 2024-02-28NoNoCurrent