NORFLEX- orphenadrine citrate tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)
Available from:
Advanced Rx Pharmacy of Tennessee, LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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.
Authorization status:
Abbreviated New Drug Application
Authorization number:
80425-0117-1

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NORFLEX- orphenadrine citrate tablet, extended release

Advanced Rx Pharmacy of Tennessee, LLC

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Orphenadrine Citrate 100mg tablets # 30

Dosage and Administration Section

DOSAGE AND ADMINISTRATION

Adults

Two tablets per day; one in the morning and one in the evening.

Indications and Usage Section

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.

Principal Display Panel

NORFLEX

orphenadrine citrate tablet, extended release

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:8 0 425-0 117(NDC:4338 6 -48 0 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O RPHENADRINE CITRATE (UNII: X0 A40 N8 I4S) (ORPHENADRINE - UNII:AL8 0 5O9 OG9 )

ORPHENADRINE CITRATE

10 0 mg

Advanced Rx Pharmacy of Tennessee, LLC

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 425-0 117-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /19 /19 9 8

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 28 4

0 6 /19 /19 9 8

Labeler -

Advanced Rx Pharmacy of T ennessee, LLC (117023142)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Advanced Rx Pharmacy o f Tennessee, LLC

1170 23142

re pa c k(8 0 425-0 117)

Revised: 12/2020

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