Amoxicillin
Amoxicillin Powder for Oral SuspensionRx Only11/2009
Approved
Approval ID
7aef59fd-9baf-48eb-a16b-1b2ceafd3d84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-139
Application NumberANDA065325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2011
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMOXICILLINActive
Quantity: 200 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT