Label: METAXALONE tablet
- NDC Code(s): 80175-0472-9
- Packager: Central Packaging
- This is a repackaged label.
- Source NDC Code(s): 64980-472
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 25, 2021
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- Official Label (Printer Friendly)
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INDICATIONS & USAGE
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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
METAXALONE
metaxalone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80175-0472(NDC:64980-472) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y) METAXALONE 800 mg Product Characteristics Color pink Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code AC127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80175-0472-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2018 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 Business Operations Central Packaging, LLC 117617671 repack(80175-0472)
