Amoxicillin
These highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974
Approved
Approval ID
1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652
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.
Amoxicillin
PRODUCT DETAILS
NDC Product Code50090-6355
Application NumberANDA065334
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 12, 2022
Generic NameAmoxicillin
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT