Prescription drug · NDA
Nuvessa (metronidazole) NDC 0642-7466
Metronidazole 65 mg/5g · Gel · Topical · Exeltis USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0642-7466-05 | 00642746605 | 1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATORMarketed from Mar 10, 2018 | |
| 0642-7466-06 | 00642746606 | 1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATORMarketed from Mar 10, 2018 · Sample package |
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)
- Nuvessa
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 65 mg/5g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Exeltis USA, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205223
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5SPL ID 09d13114-f228-f0bc-e063-6394a90a84f5SPL set ID 3b6ff39d-f84b-43b3-9b07-c0521c6d7968RxCUI 1604336, 1608253UNII 140QMO216E
- Pharmacologic class
- Nitroimidazole Antimicrobial
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400642746605followed by a unit qualifier and the quantityPackage 00642-7466-05. 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)
NUVESSA is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. NUVESSA is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.