Metaxalone (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

HOW SUPPLIED

Metaxalone Tablets, USP is available as 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing ‘AN’ on the left side of the scoring and ‘553’ on the right side of the scoring. Other side of the tablet is plain.

They are available as follows:

Bottles of 30: NDC 53746-553-30

Bottles of 100: NDC 53746-553-01

Bottles of 500: NDC 53746-553-05

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Distributed By:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 07-2018-02

PRINCIPAL DISPLAY PANEL

NDC 53746-553-30

Metaxalone Tablets USP, 800 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

1
(click image for full-size original)
METAXALONE
metaxalone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-553
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METAXALONE (METAXALONE) METAXALONE 800 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
FD&C RED NO. 40
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
Product Characteristics
Color PINK (light pink to pink) Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code AN;553
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-553-30 30 TABLET in 1 BOTTLE None
2 NDC:53746-553-01 100 TABLET in 1 BOTTLE None
3 NDC:53746-553-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203399 05/31/2013
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS (53746-553), LABEL (53746-553), MANUFACTURE (53746-553), PACK (53746-553)

Revised: 12/2019 Amneal Pharmaceuticals of New York LLC

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