Lorzone
Approved
Approval ID
cd269b7c-3bcf-4caf-8f37-3724eea8256d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2017
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
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 Code55700-517
Application NumberANDA040861
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorzoxazone
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2017
FDA Product Classification
INGREDIENTS (8)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
CHLORZOXAZONEActive
Quantity: 375 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT