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FDA Approval

EPINEPHRINE

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

FDA Approval Summary

Company
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Effective Date
February 4, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Epinephrine(0.1 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

HF Acquisition Co LLC, DBA HealthFirst

045657305

Manufacturing Establishments1

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

HF Acquisition Co LLC, DBA HealthFirst

HF Acquisition Co LLC, DBA HealthFirst

HF Acquisition Co LLC, DBA HealthFirst

045657305

Products1

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

EPINEPHRINE

Product Details

NDC Product Code
51662-1381
Route of Administration
INTRACARDIAC, INTRAVENOUS
Effective Date
February 4, 2021
SODIUM BISULFITEInactive
Code: TZX5469Z6IClass: IACT
Code: YKH834O4BHClass: ACTIBQuantity: 0.1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
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