FDA.reportPublic FDA data

Olumiant

Product NDC
0002-4182
11-digit product format
000024182
Labeler code
0002
Product ID
0002-4182_609e7391-6d27-4d0d-bd00-f9cdb75a3070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baricitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA207924
Marketing category
NDA
Marketing start
2018-05-31
Substance
BARICITINIB
Active strength
2 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olumiant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BARICITINIB2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISP4442I3Y

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
0002-4182-30Olumiant30 in 1 BOTTLETABLET, FILM COATED3028
0002-4182-61Olumiant30 in 1 BOTTLETABLET, FILM COATED3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-4182-30EA - Each0002-4182c816e485-2ecf-4ffa-b893-460cbd870fd412018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-4182OLUMIANT (BARICITINIB) TABLET, FILM COATED [ELI LILLY AND COMPANY]23Current NDC, Legacy NDC, 2 package rows20241206_866e9f35-9035-4581-a4b1-75a621ab55cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2205472baricitinib 1 MG Oral TabletPSN866e9f35-9035-4581-a4b1-75a621ab55cf28
2047241baricitinib 2 MG Oral TabletPSN866e9f35-9035-4581-a4b1-75a621ab55cf28
2588561baricitinib 4 MG Oral Tablet (EUA)PSN866e9f35-9035-4581-a4b1-75a621ab55cf28
2205474Olumiant 1 MG Oral TabletPSN866e9f35-9035-4581-a4b1-75a621ab55cf28
2047247Olumiant 2 MG Oral TabletPSN866e9f35-9035-4581-a4b1-75a621ab55cf28
2601725Olumiant 4 MG Oral TabletPSN866e9f35-9035-4581-a4b1-75a621ab55cf28
2205474baricitinib 1 MG Oral Tablet [Olumiant]SBD866e9f35-9035-4581-a4b1-75a621ab55cf28
2047247baricitinib 2 MG Oral Tablet [Olumiant]SBD866e9f35-9035-4581-a4b1-75a621ab55cf28
2601725baricitinib 4 MG Oral Tablet [Olumiant]SBD866e9f35-9035-4581-a4b1-75a621ab55cf28
2205472baricitinib 1 MG Oral TabletSCD866e9f35-9035-4581-a4b1-75a621ab55cf28
2047241baricitinib 2 MG Oral TabletSCD866e9f35-9035-4581-a4b1-75a621ab55cf28
2588561baricitinib 4 MG Oral TabletSCD866e9f35-9035-4581-a4b1-75a621ab55cf28
2588561baricitinib 4 MG Oral Tablet (EUA)SY866e9f35-9035-4581-a4b1-75a621ab55cf28
2205474Olumiant 1 MG Oral TabletSY866e9f35-9035-4581-a4b1-75a621ab55cf28
2047247Olumiant 2 MG Oral TabletSY866e9f35-9035-4581-a4b1-75a621ab55cf28
2601725Olumiant 4 MG Oral TabletSY866e9f35-9035-4581-a4b1-75a621ab55cf28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-4182-300000241823030 TABLET, FILM COATED in 1 BOTTLE (0002-4182-30) 2018-05-310000-00-00NoNoCurrent
0002-4182-610000241826130 TABLET, FILM COATED in 1 BOTTLE (0002-4182-61) 2018-05-310000-00-00YesNoCurrent