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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
Effective Date
July 22, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Epinephrine(0.3 mg in 1 1)

Manufacturing Establishments1

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

Rebel Distributors Corp

Rebel Distributors Corp

118802834

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
21695-947
Application Number
NDA020800
Marketing Category
NDA authorized generic (C73605)
Route of Administration
SUBCUTANEOUS
Effective Date
February 17, 2011
Code: YKH834O4BHClass: ACTIBQuantity: 0.3 mg in 1 1
CHLOROBUTANOLInactive
Code: HM4YQM8WRCClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6IClass: IACT
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