AMOXICILLIN AND CLAVULANATE POTASSIUM

Basic Information

Product Name

FDA Product Code

70518-2625

Regulatory Information

NDC Product Code

70518-2625

Application Number

ANDA205707

Marketing Category

C73584

Effective Date

March 4, 2024

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

AMOXICILLIN

Quantity: 500 mg in 1 1

Code: 804826J2HU

Class Code: ACTIM

ETHYLCELLULOSE (10 MPA.S)

Code: 3DYK7UYZ62

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

CLAVULANATE POTASSIUM

Quantity: 125 mg in 1 1

Code: Q42OMW3AT8

Class Code: ACTIM

Active Moieties

AMOXICILLIN ANHYDROUS

Code: 9EM05410Q9

CLAVULANIC ACID

Code: 23521W1S24

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYPROMELLOSE 2910 (5 MPA.S)

SILICON DIOXIDE

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

PROPYLENE GLYCOL

SODIUM STARCH GLYCOLATE TYPE A POTATO

TITANIUM DIOXIDE

ETHYLCELLULOSE (10 MPA.S)

TALC

Active Moieties

AMOXICILLIN ANHYDROUS

CLAVULANIC ACID