Acetazolamide
acetaZOLAMIDE Tablets, USP Rx only
Approved
Approval ID
c19166fa-2cef-4c96-a956-ea540a8ba9c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Eywa Pharma Inc
DUNS: 080465609
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetazolamide
PRODUCT DETAILS
NDC Product Code71930-009
Application NumberANDA211556
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameAcetazolamide
INGREDIENTS (6)
ACETAZOLAMIDEActive
Quantity: 250 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
Acetazolamide
PRODUCT DETAILS
NDC Product Code71930-008
Application NumberANDA211556
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameAcetazolamide
INGREDIENTS (6)
ACETAZOLAMIDEActive
Quantity: 125 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT