CHLORZOXAZONE
For Painful Musculoskeletal ConditionsPRESCRIBING INFORMATION
Approved
Approval ID
7e2ce1bc-f5ec-4f0d-81e2-975ceb2b6e49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2020
Manufacturers
FDA
i3 Pharmaceuticals, LLC
DUNS: 080127275
Products 2
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 Code72319-168
Application NumberANDA212053
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2020
FDA Product Classification
INGREDIENTS (8)
CHLORZOXAZONEActive
Quantity: 750 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CHLORZOXAZONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72319-169
Application NumberANDA212053
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2020
FDA Product Classification
INGREDIENTS (8)
CHLORZOXAZONEActive
Quantity: 375 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT