CHLORZOXAZONE
Chlorzoxazone Tablets, USP
Approved
Approval ID
669afcc1-d587-4dc0-8f6e-99109bcfed36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHLORZOXAZONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-2009
Application NumberANDA089853
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CHLORZOXAZONEActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB