Orphenadrine Citrate

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

Company

DUNS: 801503249

Effective Date

October 4, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Orphenadrine(100 mg in 1 1)

Products1

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

NDC Product Code

33261-088

Application Number

ANDA040284

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 4, 2012

Ingredients

Code: X0A40N8I4SClass: ACTIBQuantity: 100 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT