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FDA Approval

Ephedrine Sulfate

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

FDA Approval Summary

Company
Effective Date
September 24, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ephedrine(50 mg in 1 mL)

Products1

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

Ephedrine Sulfate

Product Details

NDC Product Code
0641-6238
Application Number
ANDA214334
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
September 24, 2020
EphedrineActive
Code: U6X61U5ZEGClass: ACTIBQuantity: 50 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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