Label: CHLORZOXAZONE tablet
- NDC Code(s): 80175-0085-9
- Packager: Central Packaging
- This is a repackaged label.
- Source NDC Code(s): 70954-085
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 5, 2021
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INDICATIONS & USAGE
Chlorzoxazone 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 this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
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INGREDIENTS AND APPEARANCE
CHLORZOXAZONE
chlorzoxazone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80175-0085(NDC:70954-085) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORZOXAZONE (UNII: H0DE420U8G) (CHLORZOXAZONE - UNII:H0DE420U8G) CHLORZOXAZONE 500 mg Product Characteristics Color white Score 2 pieces Shape CAPSULE (capsule shaped tablet) Size 17mm Flavor Imprint Code n085 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80175-0085-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212254 09/12/2019 Labeler - Central Packaging (117617671) Establishment Name Address ID/FEI Business Operations Central Packaging, LLC 117617671 repack(80175-0085)