Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Gland Pharma Limited
918601238
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
68083-495Application Number
ANDA216146Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 12, 2022EphedrineActive
Code: U6X61U5ZEGClass: ACTIBQuantity: 50 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT