amoxicillin and clavulanate potassium
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
58a20183-4eb6-438e-bd1e-a74f4645bb0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2016
Manufacturers
FDA
Dr. Reddy's Laboratories Inc
DUNS: 802315887
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amoxicillin and clavulanate potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-206
Application NumberNDA050564
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2016
FDA Product Classification
INGREDIENTS (9)
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
amoxicillin and clavulanate potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-213
Application NumberNDA050725
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2016
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
AMOXICILLINActive
Quantity: 200 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 28.5 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
amoxicillin and clavulanate potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-204
Application NumberNDA050575
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2016
FDA Product Classification
INGREDIENTS (8)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
AMOXICILLINActive
Quantity: 250 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 62.5 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
amoxicillin and clavulanate potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-208
Application NumberNDA050725
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2016
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 57 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
amoxicillin and clavulanate potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-218
Application NumberNDA050564
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2016
FDA Product Classification
INGREDIENTS (9)
AMOXICILLINActive
Quantity: 250 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
amoxicillin and clavulanate potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-221
Application NumberNDA050720
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2016
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT