MedPath

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

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