MedPath
FDA Product

Cephalexin

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

Basic Information

Cephalexin

53002-2181

Regulatory Information

53002-2181

ANDA062702

C73584

December 31, 2020

USA

These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral useInitial U.S. Approval: 1971

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

147096275

Active Ingredients

CEPHALEXIN

Quantity: 500 mg in 1 1

Code: OBN7UDS42Y

Class Code: ACTIM

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Code: K679OBS311

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

CEPHALEXIN ANHYDROUS

Code: 5SFF1W6677

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