Prescription drug · NDA
Vandazole (Metronidazole) NDC 0245-0860
Metronidazole 7.5 mg/g · Gel · Vaginal · Upsher-smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-0860-70 | 0024508607000245086070 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATORMarketed from Oct 4, 2005 |
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)
- Vandazole
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 7.5 mg/g
- Dosage form
- Gel
- Route
- Vaginal
- Labeler
- Upsher-smith Laboratories, LLCNDC labeler code 0245
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021806
- Marketing start
- Marketing end
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73SPL ID 44ff0133-9823-f57e-e063-6294a90a5c73SPL set ID 27d71471-8f89-4a1e-8c55-020a58961454RxCUI 142046, 608934UNII 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 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
N400245086070followed by a unit qualifier and the quantityPackage 00245-0860-70. 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)
VANDAZOLE ® is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females. VANDAZOLE is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in post-menarchal females. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0245-0860
- What is NDC 0245-0860?
- 0245-0860 is the product NDC for Vandazole (metronidazole), Metronidazole 7.5 mg/g gel, listed with the FDA by Upsher-smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vandazole (Metronidazole).
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- Upsher-smith Laboratories, LLC, NDC labeler code 0245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vandazole?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.