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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
August 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ephedrine(50 mg in 1 mL)

Manufacturing Establishments1

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

Dr. Reddy's Laboratories Limited

Dr. Reddy's Laboratories, Inc.

650446243

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
43598-725
Application Number
ANDA212649
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 24, 2018
EphedrineActive
Code: U6X61U5ZEGClass: ACTIBQuantity: 50 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
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