Prescription Drug Information: Metaxalone

METAXALONE- metaxalone tablet
Central Packaging

Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

Metaxalone -- Bottle
(click image for full-size original)

METAXALONE
metaxalone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80175-0472(NDC:64980-472)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METAXALONE (METAXALONE) METAXALONE 800 mg
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code AC127
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80175-0472-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208774 09/24/2018
Labeler — Central Packaging (117617671)
Establishment
Name Address ID/FEI Operations
Central Packaging, LLC 117617671 repack (80175-0472)

Revised: 02/2021 Central Packaging

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.