Acetazolamide
AcetaZOLAMIDE Tablets, USP Rx only
Approved
Approval ID
3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetazolamide
PRODUCT DETAILS
NDC Product Code71205-308
Application NumberANDA209734
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 1, 2019
Generic NameAcetazolamide
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
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT