Acetazolamide
Acetazolamide Extended-Release Capsules These highlights do not include all the information needed to use Acetazolamide safely and effectively. See full prescribing information for Acetazolamide Acetazolamide (Acetazolamide) CAPSULE, EXTENDED RELEASE for ORAL use. Initial U.S. Approval:
Approved
Approval ID
98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3132
Application NumberANDA090779
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2020
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ACETAZOLAMIDEActive
Quantity: 500 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT