Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
W. R. Grace & Co.-Conn.
Akorn
788779192
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Orphenadrine Citrate
Product Details
NDC Product Code
17478-538Application Number
ANDA040484Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 29, 2024OrphenadrineActive
Code: X0A40N8I4SClass: ACTIBQuantity: 30 mg in 1 mL
Sodium MetabisulfiteInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2.0 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.8 mg in 1 mL
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT