Epinephrine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 078627620

Effective Date

October 5, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Epinephrine(0.1 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

BPI LABS LLC

DUNS Number

078627620

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

54288-155

Route of Administration

INTRAVENOUS, INTRACARDIAC

Effective Date

October 5, 2023

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 8.6 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACTQuantity: 0.5 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: YKH834O4BHClass: ACTIBQuantity: 0.1 mg in 1 mL