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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
January 31, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Epinephrine(0.3 mg in 0.3 mL)

Products2

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
0093-5986
Application Number
ANDA090589
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, SUBCUTANEOUS
Effective Date
January 31, 2021
Code: YKH834O4BHClass: ACTIBQuantity: 0.3 mg in 0.3 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM TARTRATE DIHYDRATEInactive
Code: DIA7C37AOWClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Epinephrine

Product Details

NDC Product Code
0093-5985
Application Number
ANDA090589
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, SUBCUTANEOUS
Effective Date
January 31, 2021
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: YKH834O4BHClass: ACTIBQuantity: 0.15 mg in 0.3 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM TARTRATE DIHYDRATEInactive
Code: DIA7C37AOWClass: IACT
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