Source: FDA, National Drug Code (US) Revision Year: 2021
KEFLEX (cephalexin) Capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-Ī±-Amino-Ī±-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4Sā¢H2O and the molecular weight is 365.41.
Cephalexin has the following structural formula:
Each capsule contains cephalexin monohydrate equivalent to 250 mg, 500 mg or 750 mg of cephalexin. The capsules also contain carboxymethylcellulose sodium, D&C Yellow No. 10, dimethicone, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
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250 mg capsules: a white to light yellow powder filled into an opaque white and opaque dark green capsule that is imprinted with KEFLEX 250 mg in edible black ink on the white body. 500 mg capsules: a white to light yellow powder filled into an opaque light green and opaque dark green capsule that is imprinted with KEFLEX 500 mg in edible black ink on the light green body. 750 mg capsules: a white to light yellow powder filled into an elongated opaque dark green and opaque dark green capsule that is imprinted KEFLEX 750 mg in edible white ink on the dark green body. |
| How Supplied |
|---|
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KEFLEX (cephalexin) Capsules, USP, is supplied as follows:
Manufactured in Austria for: Pragma Pharmaceuticals, LLC Distributed by: Fera Pharmaceuticals, LLC, Locust Valley, N.Y. 11560 |
| Drug | Countries | |
|---|---|---|
| KEFLEX | Austria, Australia, Brazil, Cyprus, Estonia, Ireland, Japan, Malta, Mexico, Romania, United States, South Africa |
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