FDA.reportPublic FDA data

ESBRIET

Product NDC
50242-123
11-digit product format
502420123
Labeler code
50242
Product ID
50242-123_86848f3d-1ab2-457b-9f36-eba22bea36dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIRFENIDONE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA208780
Marketing category
NDA
Marketing start
2017-01-11
Marketing end
2029-03-31
Substance
PIRFENIDONE
Active strength
801 mg/1
Pharmacologic classes
Pyridone [EPC], Pyridones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ESBRIET

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIRFENIDONE801 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7NLD2JX7U
Rxcui1592279, 1592285, 1868014, 1868016, 1868018, 1868020

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50242-123-012024-01-30C16284748780-11030e365-6cc7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules and film-coated tablets, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-123-01ESBRIET1 in 1 CARTONTABLET, COATED121
50242-123-01ESBRIET90 in 1 BOTTLE, PLASTICTABLET, COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-123-01EA - Each50242-1238fed2651-df96-4bd1-924a-7de4a28ee6fa12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIRFENIDONEACTIVE INGREDIENTD7NLD2JX7UESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
PIRFENIDONEACTIVE MOIETYD7NLD2JX7UESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-123ESBRIET (PIRFENIDONE) CAPSULE ESBRIET (PIRFENIDONE) TABLET, COATED [GENENTECH, INC.]17Current NDC, Legacy NDC, 2 package rows20241122_2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1592285Esbriet 267 MG Oral CapsulePSN2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868016Esbriet 267 MG Oral TabletPSN2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868020Esbriet 801 MG Oral TabletPSN2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1592279pirfenidone 267 MG Oral CapsulePSN2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868014pirfenidone 267 MG Oral TabletPSN2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868018pirfenidone 801 MG Oral TabletPSN2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1592285pirfenidone 267 MG Oral Capsule [Esbriet]SBD2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868016pirfenidone 267 MG Oral Tablet [Esbriet]SBD2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868020pirfenidone 801 MG Oral Tablet [Esbriet]SBD2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1592279pirfenidone 267 MG Oral CapsuleSCD2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868014pirfenidone 267 MG Oral TabletSCD2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868018pirfenidone 801 MG Oral TabletSCD2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1592285Esbriet 267 MG Oral CapsuleSY2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868016Esbriet 267 MG Oral TabletSY2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21
1868020Esbriet 801 MG Oral TabletSY2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-123-01502420123011 BOTTLE, PLASTIC in 1 CARTON (50242-123-01) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2017-01-112029-03-31NoNoCurrent