MedPath
FDA Product

Amoxicillin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amoxicillin

50090-1797

Regulatory Information

50090-1797

ANDA065271

C73584

September 23, 2019

USA

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

Human Prescription Drug Label

4

Company Information

830016429

Active Ingredients

AMOXICILLIN

Quantity: 500 mg in 1 1

Code: 804826J2HU

Class Code: ACTIM

Inactive Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

AMOXICILLIN ANHYDROUS

Code: 9EM05410Q9

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