Prescription drug · ANDA
Fidaxomicin NDC 60505-4833
Fidaxomicin 200 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4833-2 | 60505483302 | 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 3, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219559
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 60505-4833_a9a2681d-631b-f559-de45-a06b3723e65cSPL ID a9a2681d-631b-f559-de45-a06b3723e65cSPL set ID 6cc3e803-8935-f9b3-ab7f-fef8b1c02070RxCUI 1111106UNII Z5N076G8YQUPC 0360505483327
- 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
N460505483302followed by a unit qualifier and the quantityPackage 60505-4833-02. 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)
Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile. ( 1.2 ) 1.1 Clostridioides difficile -Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile-associated diarrhea (CDAD). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and…
Excerpt only. Read the full label for complete information.
About NDC 60505-4833
- What is NDC 60505-4833?
- 60505-4833 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. 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?
- Apotex Corp., NDC labeler code 60505. 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 | Torrent Pharmaceuticals Limited | 13668-745 | 13668-0745-21 |
| Fidaxomicin | Fidaxomicin 200 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2596 | 00480-2596-34 |