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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
Civica, Inc.
DUNS: 081373942
Effective Date
November 30, 2021
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
72572-151
Application Number
ANDA212932
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 30, 2023
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
EphedrineActive
Code: U6X61U5ZEGClass: ACTIBQuantity: 50 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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