Source: FDA, National Drug Code (US) Revision Year: 2021
DIFICID (fidaxomicin) is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4-O- (3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)2Omethylβ-D-mannopyranosyl]oxy]methyl]12[[6-deoxy-5-C-methyl-4-O- (2-methyl-1-oxopropyl)-β-D-lyxo-hexopyranosyl]oxy]-11-ethyl-8-hydroxy-18-[(1R)-1-hydroxyethyl]-9,13,15-trimethyl-, (3E,5E,8S,9E,11S,12R,13E,15E,18S)-. The structural formula of fidaxomicin is shown in Figure 1.
Figure 1. Structural Formula of Fidaxomicin:
DIFICID tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, and titanium dioxide.
DIFICID for oral suspension is supplied as granules in bottles containing 5.45 g of fidaxomicin (40 mg of fidaxomicin per mL after reconstitution) and the following inactive ingredients: citric acid, microcrystalline cellulose, mixed berry flavor, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, and xanthan gum.
| Dosage Forms and Strengths |
|---|
DIFICID tablets200 mg white to off-white film-coated, oblong tablets; each tablet is debossed with “FDX” on one side and “200” on the other side. DIFICID for oral suspensionWhite to yellowish white granules; following reconstitution, each mL of white to yellowish white oral suspension contains 40 mg of fidaxomicin (200 mg of fidaxomicin per 5 mL). |
| How Supplied |
|---|
TabletsDIFICID tablets are white to off-white film-coated, oblong tablets containing 200 mg of fidaxomicin per tablet; each tablet is debossed with “FDX” on one side and “200” on the other side. DIFICID tablets are supplied as bottles of 20 tablets (NDC 52015-080-01). Granules for Oral SuspensionDIFICID granules for oral suspension are white to yellowish white. DIFICID granules for oral suspension (NDC 52015-700-22) is supplied as 150 mL amber glass bottles of 9.53 g of granules that contain 5.45 g of fidaxomicin. Each glass bottle has a child-resistant cap and is sealed in a laminated aluminum foil pouch. After reconstitution, the total oral suspension volume is 136 mL. Discard unused suspension after 12 days. The concentration of fidaxomicin is 40 mg/mL (200 mg per 5 mL) in the reconstituted oral suspension. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA |
| Drug | Countries | |
|---|---|---|
| DIFICID | Canada, United States |
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