methazolamide
Approved
Approval ID
8e162b6d-8fa6-45f6-80d8-5132d94c1207
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Effcon Laboratories, Inc.
DUNS: 185886769
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methazolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55806-020
Application NumberANDA040062
Product Classification
M
Marketing Category
C73584
G
Generic Name
methazolamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHAZOLAMIDEActive
Quantity: 50 mg in 1 1
Code: W733B0S9SD
Classification: ACTIB
methazolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55806-021
Application NumberANDA040062
Product Classification
M
Marketing Category
C73584
G
Generic Name
methazolamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
METHAZOLAMIDEActive
Quantity: 25 mg in 1 1
Code: W733B0S9SD
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT