Prescription drug · NDA
Firvanq (Vancomycin hydrochloride) NDC 65628-205
Kit · Azurity Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65628-205-10 | 6562802051065628020510 | 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLEMarketed from Jan 26, 2018 |
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)
- Firvanq
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Dosage form
- Kit
- Labeler
- Azurity Pharmaceuticals, IncNDC labeler code 65628
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208910
- Marketing start
- Listing expires
- Identifiers
- Product ID 65628-205_5693e540-a3bf-f5fe-e063-6394a90ab1ccSPL ID 5693e540-a3bf-f5fe-e063-6394a90ab1ccSPL set ID 5aca5508-b577-446c-9980-ab4c7582b4b9RxCUI 2000127, 2000133, 2000134, 2000136
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N465628020510followed by a unit qualifier and the quantityPackage 65628-0205-10. 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)
FIRVANQ is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug‑resistant bacteria and maintain the effecti…
Excerpt only. Read the full label for complete information.
About NDC 65628-205
- What is NDC 65628-205?
- 65628-205 is the product NDC for Firvanq (vancomycin hydrochloride) kit, listed with the FDA by Azurity Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Firvanq (Vancomycin hydrochloride).
- Who is the labeler?
- Azurity Pharmaceuticals, Inc, NDC labeler code 65628. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Firvanq?
- 3 other product NDCs are listed under this name. See all Firvanq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Firvanq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-204 | 65628-0204-05 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-206 | 65628-0206-05 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-208 | 65628-0208-10 |
Other NDCs under NDA 208910
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 |
|---|---|---|---|---|
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-204 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-206 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-208 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-104 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-106 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-107 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-108 |