acetazolamide
Acetazolamide Tablets USP Rx only
Approved
Approval ID
0700a910-79aa-4431-aecf-637fe14fcae8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acetazolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-287
Application NumberANDA205530
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2022
FDA Product Classification
INGREDIENTS (8)
ACETAZOLAMIDEActive
Quantity: 125 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
acetazolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-288
Application NumberANDA205530
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2022
FDA Product Classification
INGREDIENTS (8)
ACETAZOLAMIDEActive
Quantity: 250 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT