Acetazolamide
AcetaZOLAMIDE Tablets, USP
Approved
Approval ID
a0da424c-c434-45a1-9a57-e1802cc6bdef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
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 Code50090-4511
Application NumberANDA209734
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2022
FDA Product Classification
INGREDIENTS (9)
ACETAZOLAMIDEActive
Quantity: 125 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT