Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone
Product Details
NDC Product Code
63187-383Application Number
ANDA087916Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2021DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 2 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT