FDA.reportPublic FDA data

Pirfenidone

Product NDC
69097-987
11-digit product format
690970987
Labeler code
69097
Product ID
69097-987_398a92b7-8db3-4604-9004-892c41721294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pirfenidone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA212078
Marketing category
ANDA
Marketing start
2022-08-02
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69097-987-05Pirfenidone90 in 1 BOTTLETABLET, COATED903
69097-987-93Pirfenidone270 in 1 BOTTLETABLET, COATED2703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-987PIRFENIDONE TABLET, COATED PIRFENIDONE TABLET, COATED [CIPLA USA INC.]3Current NDC, Legacy NDC, 2 package rows20220831_1927bf5d-1ef3-4a36-8dac-dc0a45b72fec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868014pirfenidone 267 MG Oral TabletPSN1927bf5d-1ef3-4a36-8dac-dc0a45b72fec3
1868018pirfenidone 801 MG Oral TabletPSN1927bf5d-1ef3-4a36-8dac-dc0a45b72fec3
1868014pirfenidone 267 MG Oral TabletSCD1927bf5d-1ef3-4a36-8dac-dc0a45b72fec3
1868018pirfenidone 801 MG Oral TabletSCD1927bf5d-1ef3-4a36-8dac-dc0a45b72fec3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-987-056909709870590 TABLET, COATED in 1 BOTTLE (69097-987-05) 2022-08-020000-00-00NoNoCurrent
69097-987-9369097098793270 TABLET, COATED in 1 BOTTLE (69097-987-93) 2022-08-020000-00-00NoNoCurrent