Amoxicillin and Clavulanate Potassium

Basic Information

Product Name

FDA Product Code

50090-6381

Regulatory Information

NDC Product Code

50090-6381

Application Number

ANDA065098

Marketing Category

C73584

Effective Date

September 16, 2022

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

AMOXICILLIN

Quantity: 400 mg in 5 mL

Code: 804826J2HU

Class Code: ACTIM

CLAVULANATE POTASSIUM

Quantity: 57 mg in 5 mL

Code: Q42OMW3AT8

Class Code: ACTIM

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Code: K679OBS311

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

CARAMEL

Code: T9D99G2B1R

Class Code: IACT

ORANGE

Code: 5EVU04N5QU

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

RASPBERRY

Code: 4N14V5R27W

Class Code: IACT

Active Moieties

AMOXICILLIN ANHYDROUS

Code: 9EM05410Q9

CLAVULANIC ACID

Code: 23521W1S24

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS CITRIC ACID

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

SACCHARIN SODIUM

MICROCRYSTALLINE CELLULOSE

SILICON DIOXIDE

XANTHAN GUM

CARAMEL

ORANGE

SODIUM CITRATE, UNSPECIFIED FORM

RASPBERRY

Active Moieties

AMOXICILLIN ANHYDROUS

CLAVULANIC ACID