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 | 52015008001 | 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_21c95e9f-0a3d-4fb8-90b5-934bad817d00SPL ID 21c95e9f-0a3d-4fb8-90b5-934bad817d00SPL set ID dd966338-c820-4270-b704-09ef75fa3cebRxCUI 1111106, 1111110, 2279843, 2279847UNII Z5N076G8YQ
- 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
DIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID 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 DIFICID ® is indicated in adult and pediatric patients aged 6 months and older for the treatment of C. difficile -associated diarrhea (CDAD). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiv…
Excerpt only. Read the full label for complete information.
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 |