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FDA Product

Ampicillin

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

Basic Information

Ampicillin

10544-122

Regulatory Information

10544-122

ANDA062882

C73584

March 16, 2015

USA

AMPICILLIN CAPSULES, USP 250 mg and 500 mg AMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL Rx Only

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

171434587

Active Ingredients

AMPICILLIN TRIHYDRATE

Quantity: 500 mg in 1 1

Code: HXQ6A1N7R6

Class Code: ACTIM

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

AMPICILLIN

Code: 7C782967RD

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