Prescription drug · ANDA
metronidazole vaginal (metronidazole) NDC 70518-4572
Metronidazole 7.5 mg/g · Gel · Vaginal · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4572-0 | 70518457200 | 1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4572-0) / 70 g in 1 TUBE, WITH APPLICATORMarketed from Feb 11, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- metronidazole vaginal
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 7.5 mg/g
- Dosage form
- Gel
- Route
- Vaginal
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216750
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 70518-4572_4aa07119-00c9-2fef-e063-6394a90a4a9aSPL ID 4aa07119-00c9-2fef-e063-6394a90a4a9aSPL set ID b07f42dd-75d4-499a-984f-c06894ff3a45RxCUI 142046UNII 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
N470518457200followed by a unit qualifier and the quantityPackage 70518-4572-00. 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)
INDICATIONS AND USAGE Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216750
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 |
|---|---|---|---|---|
| metronidazole vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | Saptalis Pharmaceuticals LLC | 71656-067 |