Amoxicillin
Amoxicillin for Oral Suspension, USP
Approved
Approval ID
f27aa99b-2b77-48d6-8af4-3ae26c04d5b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-296
Application NumberANDA065334
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT