Orphenadrine Citrate
ORPHENADRINE CITRATE INJECTION, USP Rx Only
Approved
Approval ID
aec8ad3a-f717-4e74-b7b9-19debdaad79a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2016
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-3222
Application NumberANDA084779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 29, 2018
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ORPHENADRINE CITRATEActive
Quantity: 30 mg in 1 mL
Code: X0A40N8I4S
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 0.91 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 2.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT