Drug Catalog - Product Detail
ORPHENADRINE CITRATE ER TB 100MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43386-0480-24 | LUPIN PHARMACEUTICALS | 100 | 100MG | TABLET |
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Description
DESCRIPTION Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-〈-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C 18 H 23 NO•C 6 H 8 O 7 and molecular weight of 461.51. It has the following structural formula: Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate. Structure
How Supplied
HOW SUPPLIED Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: NDC 43386-480-24 in bottles of 100 tablets NDC 43386-480-26 in bottles of 500 tablets NDC 43386-480-28 in bottles of 1000 tablets Storage and Handling Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 for GAVIS Pharmaceuticals, LLC 400 Campus Drive Somerset, NJ 08873 GIN-480-01 Rev: 02/2011
Indications & Usage
INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults Two tablets per day; one in the morning and one in the evening.