Orphenadrine Citrate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 119723554

Effective Date

July 20, 2016

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Orphenadrine(30 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0591-3222

Application Number

ANDA084779

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Effective Date

November 29, 2018

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X0A40N8I4SClass: ACTIBQuantity: 30 mg in 1 mL

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACTQuantity: 0.91 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 2.9 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT