MedPath

Epinephrine

EPINEPHRINE INJECTION, USP

Approved
Approval ID

daa651e5-40e1-4e87-9775-3f7cc44dff32

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 24, 2011

Manufacturers
FDA

American Regent, Inc.

DUNS: 622781813

Products 1

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

Epinephrine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0517-1130
Product Classification
G
Generic Name
Epinephrine
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS
Effective DateAugust 24, 2011
FDA Product Classification

INGREDIENTS (5)

CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
EPINEPHRINEActive
Quantity: 1 mg in 1 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Epinephrine - FDA Drug Approval Details