Augmentin
Approved
Approval ID
d567412a-e5ed-4c7f-90f0-ea3039786480
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amoxicillin and clavulante potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0388
Application NumberNDA050564
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulante potassium
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (9)
AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
amoxicillin and clavulante potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3903
Application NumberNDA050720
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulante potassium
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (9)
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
amoxicillin and clavulante potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0387
Application NumberNDA050564
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulante potassium
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (9)
AMOXICILLINActive
Quantity: 250 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT