Baricitinib Tablets, For Oral Use

Baricitinib Tablets, For Oral Use
SPL v3
SPL
SPL Set ID 7052c055-fedf-453b-86bc-01f5465eb157
Route
ORAL
Published
Effective Date 2022-02-23
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baricitinib (4 mg)
Inactive Ingredients
Mannitol Cellulose, Microcrystalline Croscarmellose Sodium Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: Lilly;4 Shape: round Color: pink Size: 9 mm Score: 1
Marketing Status
EMERGENCY USE AUTHORIZATION Active Since 2021-12-20
Description

FACT SHEET FOR HEALTHCARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses. Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Medication Information

Description

FACT SHEET FOR HEALTHCARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses. Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Section 42229-5

FACT SHEET FOR HEALTHCARE PROVIDERS

EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses.

Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Package Label – Baricitinib 4 Mg 30ct Bottle

Rx Only

NDC 0002-6885-30

baricitinib

tablets

4 mg

For use under Emergency Use Authorization (EUA).

30 tablets

Lilly

Structured Label Content

Section 42229-5 (42229-5)

FACT SHEET FOR HEALTHCARE PROVIDERS

EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses.

Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Package Label – Baricitinib 4 Mg 30ct Bottle (PACKAGE LABEL – BARICITINIB 4 mg 30ct Bottle)

Rx Only

NDC 0002-6885-30

baricitinib

tablets

4 mg

For use under Emergency Use Authorization (EUA).

30 tablets

Lilly

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:00.642415 · Updated: 2026-03-14T21:48:23.957578