Firvanq (vancomycin hydrochloride) NDC 65628-208

NDC codes

FDA NDC Directory

Product NDC (as listed)65628-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65628-0208Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65628-208-10	65628020810	1 KIT in 1 CARTON (65628-208-10) * 15 g in 1 BOTTLE * 289 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, Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208910
Marketing start: Jan 26, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 65628-208_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

N465628020810 followed by a unit qualifier and the quantity

Package 65628-0208-10. 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 Jul 14, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208910

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208910
Product	Strength	Form · route	Labeler	Product NDC
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
Firvanqvancomycin hydrochloride	—	Kit	Azurity Pharmaceuticals, Inc	65628-205
Firvanqvancomycin hydrochloride	—	Kit	Azurity Pharmaceuticals, Inc	65628-204
Firvanqvancomycin hydrochloride	—	Kit	Azurity Pharmaceuticals, Inc	65628-206