Prescription drug · ANDA
Fidaxomicin NDC 0480-2596
Fidaxomicin 200 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-2596-34 | 00480259634 | 20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)Marketed from Jul 15, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Fidaxomicin
- Generic name (nonproprietary)
- fidaxomicin
- Active ingredients
- Fidaxomicin — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208443
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 0480-2596_2b91a4ed-fd17-4794-ab84-877d8ad45f48SPL ID 2b91a4ed-fd17-4794-ab84-877d8ad45f48
- Pharmacologic class
- Macrolide 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
N400480259634followed by a unit qualifier and the quantityPackage 00480-2596-34. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0480-2596
- What is NDC 0480-2596?
- 0480-2596 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fidaxomicin.
- What is the active ingredient?
- Fidaxomicin.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fidaxomicin?
- 3 other product NDCs are listed under this name. See all Fidaxomicin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fidaxomicin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fidaxomicin | Fidaxomicin 200 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5194 | 00781-5194-20 |
| Fidaxomicin | Fidaxomicin 200 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4833 | 60505-4833-02 |
| Fidaxomicin | Fidaxomicin 200 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-745 | 13668-0745-21 |