Baricitinib

Product NDC
0002-6885
11-digit product format
000026885
Labeler code
0002
Product ID
0002-6885_14a2ffe3-1d7e-4d1b-ac44-1698d5f92da4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baricitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eli Lilly and Company
Marketing category
EMERGENCY USE AUTHORIZATION
Marketing start
2021-12-20
Substance
BARICITINIB
Active strength
4 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Baricitinib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BARICITINIB4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ISP4442I3YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2588561Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7052c055-fedf-453b-86bc-01f5465eb157Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92e5828b-7454-4bec-a43d-8649c48167b3Product name220200305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-6885-30Baricitinib30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-6885BARICITINIB TABLET, FILM COATED [ELI LILLY AND COMPANY]3Current NDC, Legacy NDC, 1 package rows20220608_7052c055-fedf-453b-86bc-01f5465eb157.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaricitinibBARICITINIBEli Lilly and Company7052c055-fedf-453b-86bc-01f5465eb1572022-05-10Exact identifier
ndc (product): 0002-6885

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588561baricitinib 4 MG Oral Tablet (EUA)PSN7052c055-fedf-453b-86bc-01f5465eb1573
2588561baricitinib 4 MG Oral TabletSCD7052c055-fedf-453b-86bc-01f5465eb1573
2588561baricitinib 4 MG Oral Tablet (EUA)SY7052c055-fedf-453b-86bc-01f5465eb1573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-6885-300000268853030 TABLET, FILM COATED in 1 BOTTLE (0002-6885-30) 2021-12-200000-00-00NoNoCurrent