Orphenadrine Citrate
ORPHENADRINE CITRATE INJECTION, USP
Approved
Approval ID
56bc8e4a-6771-476d-95e8-e4ef2d869cb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2024
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Orphenadrine Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-538
Application NumberANDA040484
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (5)
Orphenadrine CitrateActive
Quantity: 30 mg in 1 mL
Code: X0A40N8I4S
Classification: ACTIB
Sodium MetabisulfiteInactive
Quantity: 2.0 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Quantity: 5.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT