Amoxicillin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 801503249

Effective Date

March 27, 2014

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Amoxicillin(250 mg in 5 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

33261-726

Application Number

ANDA065322

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 28, 2014

Ingredients

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

Code: 804826J2HUClass: ACTIMQuantity: 250 mg in 5 mL

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT