Rx Item-Orphenadrine Citrate 30Mg/Ml Vial 10X2Ml By Akorn Pharma Gen Norflex

Clinical Information
Gen. Code and Des.
4593 orphenadrine citrate INJECTION VIAL 30 MG/ML
GCN and Des.
17653 orphenadrine citrate INJECTION VIAL 30 MG/ML
Strength
30MG/ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
12209200 SKELETAL MUSCLE RELAXANTS, MISCELLANEOUS
Active Ingredients
1649 orphenadrine citrate 4682364
Inactive Ingredients
6300 sulfite 14265453
FDA NDA Approved



ORPHENADRINE CITRATE- orphenadrine citrate injection
Akorn, Inc.

Rx only

DESCRIPTION:

Orphenadrine citrate is the citrate salt of orphenadrine ((�)-N, N-Dimethyl- 2-[(o-methyl-a-phenylbenzyl)oxy]ethylamine citrate (1:1)) with a molecular weight of 461.50; empirical formula C18 H23 NO�C6 H8 O7 . The structural formula of orphenadrine citrate is:

Structural Formula
(click image for full-size original)


It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.

Orphenadrine citrate injection contains 60 mg of orphenadrine citrate in aqueous solution in each vial. Orphenadrine citrate injection also contains: sodium chloride USP 5.8 mg; sodium metabisulfite NF, 2.0 mg; sodium hydroxide NF, to adjust pH (5.0 to 6.0); and water for injection USP, q.s. to 2 mL.

CLINICAL PHARMACOLOGY:

The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

INDICATIONS AND USAGE:

Orphenadrine citrate injection is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.

RX ITEM-Orphenadrine Citrate 30Mg/Ml Via
Item No.:RX435141 NDC No.17478053802 17478-538-02 1747853802 UPC No.:317478538028 NDC No.17478-0538-02 UPC/GTIN No.3-17478-53802-8 317478538028 317478-538028 MPN 53802

Orphenadrine Citrate 30Mg/Ml Vial 10X2Ml
Item No.:RX435141 NDC No.17478053802 17478-538-02 1747853802 UPC No.:317478538028 NDC No.17478-0538-02 UPC/GTIN No.3-17478-53802-8 317478538028 317478-538028 MPN 53802

ORPHENADRINE CITRATE INJE
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