Acetazolamide
AcetaZOLAMIDE Tablets USP
Approved
Approval ID
abeb13eb-66a5-4030-9bc2-5981acd196b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2016
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-4022
Application NumberANDA040195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2016
FDA Product Classification
INGREDIENTS (9)
AcetazolamideActive
Quantity: 125 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Acetazolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4023
Application NumberANDA040195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2016
FDA Product Classification
INGREDIENTS (9)
AcetazolamideActive
Quantity: 250 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT