Acetazolamide
Acetazolamide Extended-Release Capsules Rx only Revised: 06/2022
Approved
Approval ID
43231abb-2a5d-44ab-b3e6-7564a1131ac5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2022
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
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 Code62332-349
Application NumberANDA210423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2022
FDA Product Classification
INGREDIENTS (13)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ACETAZOLAMIDEActive
Quantity: 500 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT