Amoxicillin
Amoxicillin
Approved
Approval ID
b18eca1d-0133-4266-829b-9a0bd925c4f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2009
Manufacturers
FDA
Dispensing Solutions Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55045-2992
Application NumberANDA065334
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2009
FDA Product Classification
INGREDIENTS (8)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT