Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals LLC
860156658
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone Sodium Phosphate
Product Details
NDC Product Code
70121-1399Application Number
ANDA208690Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
December 25, 2023DexamethasoneActive
Code: AI9376Y64PClass: ACTIRQuantity: 10 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 24.75 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT