Prescription drug · NDA AUTHORIZED GENERIC
Metronidazole NDC 68308-663
Metronidazole 10 mg/g · Gel · Topical · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68308-663-55 | 68308066355 | 1 BOTTLE, PUMP in 1 CARTON (68308-663-55) / 55 g in 1 BOTTLE, PUMPMarketed from Nov 10, 2023 | |
| 68308-663-60 | 68308066360 | 1 TUBE in 1 CARTON (68308-663-60) / 60 g in 1 TUBEMarketed from May 19, 2025 |
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)
- Metronidazole
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Mayne Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021789
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 68308-663_a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26bSPL ID a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26bSPL set ID 3c25a3f9-52fc-448e-a044-f63b9dadcd4aRxCUI 577237UNII 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
N468308066355followed by a unit qualifier and the quantityPackage 68308-0663-55. 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)
Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
Excerpt only. Read the full label for complete information.