Prescription drug · NDA
Noxafil (Posaconazole) NDC 0085-1328
Posaconazole 40 mg/mL · Suspension · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0085-1328-01 | 0008513280100085132801 | 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASSMarketed from Sep 15, 2006 |
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)
- Noxafil
- Generic name (nonproprietary)
- posaconazole
- Active ingredients
- Posaconazole — 40 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0085
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022003
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0085-1328_56740f7d-3b29-4786-b5c7-eea6c0f14400SPL ID 56740f7d-3b29-4786-b5c7-eea6c0f14400SPL set ID b073b082-7b57-4423-8c06-4fd4263d6f84RxCUI 665019, 665022, 1482908, 1482912, 1492043, 1492047, 2558603, 2558607UNII 6TK1G07BHZUPC 0300854324025
- Pharmacologic class
- Azole Antifungal
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
N400085132801followed by a unit qualifier and the quantityPackage 00085-1328-01. 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)
Noxafil is an azole antifungal indicated as follows: Noxafil is indicated for the treatment of invasive aspergillosis as follows: ( 1.1 ) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem …
Excerpt only. Read the full label for complete information.
About NDC 0085-1328
- What is NDC 0085-1328?
- 0085-1328 is the product NDC for Noxafil (posaconazole), Posaconazole 40 mg/mL suspension, 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?
- Noxafil (Posaconazole).
- What is the active ingredient?
- Posaconazole.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Noxafil?
- 3 other product NDCs are listed under this name. See all Noxafil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Noxafil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Noxafilposaconazole | Posaconazole 300 mg/1 | Powder, For suspensionOral | Merck Sharp & Dohme LLC | 0085-2224 | 00085-2224-02 |
| Noxafilposaconazole | Posaconazole 18 mg/mL | SolutionIntravenous | Merck Sharp & Dohme LLC | 0085-4331 | 00085-4331-01 |
| Noxafilposaconazole | Posaconazole 100 mg/1 | Tablet, CoatedOral | Merck Sharp & Dohme LLC | 0085-4324 | 00085-4324-02 |
Other NDCs under NDA 022003
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 |
|---|---|---|---|---|
| Posaconazole | Posaconazole 40 mg/mL | SuspensionOral | ENDO USA, Inc. | 0254-1016 |