ACETAZOLAMIDE EXTENDED-RELEASE
Acetazolamide Extended-Release Capsules Revised: 05/2022 Rx only
Approved
Approval ID
78f78919-a6ba-4072-bc45-2ab3637ed894
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetazolamide Extended-Release
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-243
Application NumberANDA207401
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide Extended-Release
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2022
FDA Product Classification
INGREDIENTS (18)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ACETAZOLAMIDEActive
Quantity: 500 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT