Prescription drug · NDA
Xifaxan (Rifaximin) NDC 65649-303
Rifaximin 550 mg/1 · Tablet · Oral · Salix Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65649-303-01 | 6564903030165649030301 | 3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACKMarketed from May 1, 2010 | |
| 65649-303-02 | 6564903030265649030302 | 60 TABLET in 1 BOTTLE (65649-303-02)Marketed from May 1, 2010 | |
| 65649-303-03 | 6564903030365649030303 | 6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACKMarketed from May 1, 2010 | |
| 65649-303-05 | 6564903030565649030305 | 3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACKMarketed from May 1, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xifaxan
- Generic name (nonproprietary)
- rifaximin
- Active ingredients
- Rifaximin — 550 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Salix Pharmaceuticals, Inc.NDC labeler code 65649
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021361
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 65649-303_b2e9bb84-e97e-4e7e-8a23-425418b4374dSPL ID b2e9bb84-e97e-4e7e-8a23-425418b4374dSPL set ID c5e8e2fd-7087-4b78-9181-cc259c0be2f1RxCUI 429662, 539789, 856664, 856666UNII L36O5T016N
- Pharmacologic class
- Rifamycin Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465649030301followed by a unit qualifier and the quantityPackage 65649-0303-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XIFAXAN is a rifamycin antibacterial indicated for: • Treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adu…
Excerpt only. Read the full label for complete information.
About NDC 65649-303
- What is NDC 65649-303?
- 65649-303 is the product NDC for Xifaxan (rifaximin), Rifaximin 550 mg/1 tablet, listed with the FDA by Salix Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xifaxan (Rifaximin).
- What is the active ingredient?
- Rifaximin.
- Who is the labeler?
- Salix Pharmaceuticals, Inc., NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xifaxan?
- 3 other product NDCs are listed under this name. See all Xifaxan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xifaxan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xifaxanrifaximin | Rifaximin 550 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-6777 | 55154-6777-08 |
| Xifaxanrifaximin | Rifaximin 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-2445 | 50090-2445-00 |
| Xifaxanrifaximin | Rifaximin 200 mg/1 | TabletOral | Salix Pharmaceuticals, Inc. | 65649-301 | 65649-0301-03 |
Other NDCs under NDA 021361
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xifaxanrifaximin | Rifaximin 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-2445 |
| Xifaxanrifaximin | Rifaximin 550 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-6777 |
| Xifaxanrifaximin | Rifaximin 200 mg/1 | TabletOral | Salix Pharmaceuticals, Inc. | 65649-301 |