Amoxicillin
AMOXICILLIN CAPSULES, USP 250 mg and 500 mgAMOXICILLIN TABLETS, USP 875 mgAMOXICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL
Approved
Approval ID
0fb026d7-065b-4d0c-823b-45ddef8706a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2013
Manufacturers
FDA
Liberty Pharmaceuticals, Inc.
DUNS: 012568840
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 Code0440-7100
Application NumberANDA062884
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 5, 2013
FDA Product Classification
INGREDIENTS (9)
AMOXICILLINActive
Quantity: 250 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT