Prescription drug · NDA
Dificid (Fidaxomicin) NDC 52015-080
Fidaxomicin 200 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52015-080-01 | 5201500800152015008001 | 1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from May 27, 2011 |
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)
- Dificid
- Generic name (nonproprietary)
- fidaxomicin
- Active ingredients
- Fidaxomicin — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 52015
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201699
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 52015-080_22ef2f1a-cf0e-4733-b749-2a1adfb5c917SPL ID 22ef2f1a-cf0e-4733-b749-2a1adfb5c917
- 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
N452015008001followed by a unit qualifier and the quantityPackage 52015-0080-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 52015-080
- What is NDC 52015-080?
- 52015-080 is the product NDC for Dificid (fidaxomicin), Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dificid (Fidaxomicin).
- What is the active ingredient?
- Fidaxomicin.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 52015. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dificid?
- 1 other product NDC are listed under this name. See all Dificid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dificid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dificidfidaxomicin | Fidaxomicin 200 mg/5mL | Granule, For suspensionOral | Merck Sharp & Dohme LLC | 52015-700 | 52015-0700-22 |