methazolamide
METHAZOLAMIDE TABLETS USP 25 mg and 50 mg Rx Only
Approved
Approval ID
5e0795e1-d5c5-4b04-9bce-077bb8028023
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2021
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 Code0574-0791
Application NumberANDA040062
Product Classification
M
Marketing Category
C73584
G
Generic Name
methazolamide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2021
FDA Product Classification
INGREDIENTS (6)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
METHAZOLAMIDEActive
Quantity: 50 mg in 1 1
Code: W733B0S9SD
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
methazolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-0790
Application NumberANDA040062
Product Classification
M
Marketing Category
C73584
G
Generic Name
methazolamide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2021
FDA Product Classification
INGREDIENTS (6)
METHAZOLAMIDEActive
Quantity: 25 mg in 1 1
Code: W733B0S9SD
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT