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Amoxicillin and Clavulanate Potassium

These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, and AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, and AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS (CHEWABLE). AMOXICILLIN and CLAVULANATE POTASSIUM tablets, AMOXICILLIN and CLAVULANATE POTASSIUM for oral suspension, and AMOXICILLIN and CLAVULANATE POTASSIUM tablets (chewable) for oral use Initial U.S. Approval: 1984

Approved
Approval ID

d76cf57c-777a-4619-b63b-38b72ad1d38a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2023

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

Products 2

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 Code53002-7890
Application NumberANDA065096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification

INGREDIENTS (13)

AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

Amoxicillin and Clavulanate Potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53002-2390
Application NumberANDA065101
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification

INGREDIENTS (13)

CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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