MedPath
FDA Product

Cefadroxil

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

Basic Information

Cefadroxil

57297-180

Regulatory Information

57297-180

ANDA065392

C73584

May 4, 2016

USA

Cefadroxil Capsules USP 500 mg

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

LUPIN LIMITED

675923163

Active Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

CEFADROXIL

Quantity: 500 mg in 1 1

Code: 280111G160

Class Code: ACTIM

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

Active Moieties

CEFADROXIL ANHYDROUS

Code: Q525PA8JJB

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