Amoxicillin

Basic Information

Product Name

Amoxicillin

FDA Product Code

50090-4260

Regulatory Information

NDC Product Code

50090-4260

Application Number

ANDA065334

Marketing Category

C73584

Effective Date

December 22, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

AMOXICILLIN

Quantity: 200 mg in 5 mL

Code: 804826J2HU

Class Code: ACTIM

SUCROSE

Code: C151H8M554

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

AMOXICILLIN ANHYDROUS

Code: 9EM05410Q9

Basic Information

Regulatory Information

Company Information

Active Ingredients

SUCROSE

TRISODIUM CITRATE DIHYDRATE

SODIUM BENZOATE

EDETATE DISODIUM

FD&C RED NO. 3

XANTHAN GUM

SILICON DIOXIDE

Active Moieties

AMOXICILLIN ANHYDROUS