NDC codes

FDA NDC Directory
Product NDC (as listed)0245-0860Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00245-0860Add 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 NDC11-digit (billing)PackageCopy
0245-0860-7000245086070002450860701 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

N400245086070 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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