FDA.reportPublic FDA data

Esbriet

Product NDC
64116-121
11-digit product format
641160121
Labeler code
64116
Product ID
64116-121_58cc9885-2828-435d-9db2-8e94cdecfa00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pirfenidone
Dosage form
CAPSULE
Route
ORAL
Labeler
InterMune, Inc.
Application
NDA022535
Marketing category
NDA
Marketing start
2014-10-16
Marketing end
0000-00-00
Substance
PIRFENIDONE
Active strength
267 mg/1
Pharmacologic classes
Pyridone [EPC],Pyridones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
82ab2cd4-4ada-41b1-950d-75fef25f7bacProduct name320250818
d62f4d7c-9247-4aa4-ad93-12349422d49eProduct name220240530

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64116-121-012020-01-31C16284748780-19d75b9d0-0d21-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014
64116-121-022020-01-31C16284748780-19d75b9d0-0d21-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014
64116-121-032020-01-31C16284748780-19d75b9d0-0d21-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64116-121-01Esbriet270 in 1 BOTTLE, PLASTICCAPSULE2701
64116-121-01Esbriet1 in 1 CARTONCAPSULE11
64116-121-02Esbriet1 in 1 CARTONCAPSULE11
64116-121-02Esbriet63 in 1 BLISTER PACKCAPSULE631
64116-121-03Esbriet4 in 1 CARTONCAPSULE41
64116-121-03Esbriet63 in 1 BLISTER PACKCAPSULE631

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64116-121-01EA - Each64116-12107234943-854f-4547-8cf4-c5e59a94aebb12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIRFENIDONEACTIVE INGREDIENTD7NLD2JX7UESBRIET (PIRFENIDONE) CAPSULE [INTERMUNE, INC.]1
PIRFENIDONEACTIVE MOIETYD7NLD2JX7UESBRIET (PIRFENIDONE) CAPSULE [INTERMUNE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64116-121ESBRIET (PIRFENIDONE) CAPSULE [INTERMUNE, INC.]1Legacy NDC, 6 package rows20141028_0ab861c2-d5ca-4f92-854c-6477971a1b38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1592285Esbriet 267 MG Oral CapsulePSN0ab861c2-d5ca-4f92-854c-6477971a1b381
1592279pirfenidone 267 MG Oral CapsulePSN0ab861c2-d5ca-4f92-854c-6477971a1b381
1592285pirfenidone 267 MG Oral Capsule [Esbriet]SBD0ab861c2-d5ca-4f92-854c-6477971a1b381
1592279pirfenidone 267 MG Oral CapsuleSCD0ab861c2-d5ca-4f92-854c-6477971a1b381
1592285Esbriet 267 MG Oral CapsuleSY0ab861c2-d5ca-4f92-854c-6477971a1b381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64116-121-0164116012101270 in 1 BOTTLE, PLASTICHistorical
64116-121-02641160121021 in 1 CARTONHistorical
64116-121-03641160121034 in 1 CARTONHistorical