Prescription drug · ANDA
Metronidazole NDC 51672-4215
Metronidazole 10 mg/g · Gel · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4215-3 | 51672421503 | 1 TUBE in 1 CARTON (51672-4215-3) / 60 g in 1 TUBEMarketed from Apr 9, 2019 | |
| 51672-4215-6 | 51672421506 | 1 TUBE in 1 CARTON (51672-4215-6) / 45 g in 1 TUBEMarketed from Apr 9, 2019 | |
| 51672-4215-9 | 51672421509 | 1 BOTTLE, PUMP in 1 CARTON (51672-4215-9) / 55 g in 1 BOTTLE, PUMPMarketed from Apr 9, 2019 |
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
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204651
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 51672-4215_56a665f7-d6b1-3f68-e063-6294a90afa3aSPL ID 56a665f7-d6b1-3f68-e063-6294a90afa3aSPL set ID 5842a554-58d1-4ee4-99aa-1e6029a69be2RxCUI 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
N451672421503followed by a unit qualifier and the quantityPackage 51672-4215-03. 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 USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole gel is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204651
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 | Metronidazole 10 mg/g | GelTopical | Sun Pharmaceutical Industries, Inc. | 51672-4164 |