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Epinephrine

EPINEPHRINE Injection, USP

Approved
Approval ID

2d524e06-907c-400a-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2019

Manufacturers
FDA

Sina Health Inc

DUNS: 047161553

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 Code70385-2008
Product Classification
G
Generic Name
EPINEPHRINE
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR
Effective DateFebruary 4, 2019
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EPINEPHRINEActive
Quantity: 1 mg in 1 mL
Code: YKH834O4BH
Classification: ACTIB

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/31/2012

1:1000 (1 mg/mL)

Ampul

Protect from light until ready to use.

R x only

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 8/31/2012

HOW SUPPLIED

Epinephrine Injection, USP 1:1000 (1 mg/mL) is supplied in a 1 mL ampul single-dose container (NDC 0409-7241-61).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Revised: October, 2008

Printed in USA EN-1927

Hospira, Inc., Lake Forest, IL 60045 USA

Repackaged in 2 ampule packages NDC: 70385-2008-2

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Epinephrine - FDA Drug Approval Details