Prescription drug · ANDA
Metronidazole NDC 51672-4164
Metronidazole 10 mg/g · Gel · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4164-3 | 5167241640351672416403 | 1 TUBE in 1 CARTON (51672-4164-3) / 60 g in 1 TUBEMarketed from Mar 14, 2017 | |
| 51672-4164-6 | 5167241640651672416406 | 1 TUBE in 1 CARTON (51672-4164-6) / 45 g in 1 TUBEMarketed from Mar 14, 2017 | |
| 51672-4164-9 | 5167241640951672416409 | 1 BOTTLE, PUMP in 1 CARTON (51672-4164-9) / 55 g in 1 BOTTLE, PUMPMarketed from Aug 15, 2017 |
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
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- 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 51672-4164_56a65e15-cd06-394c-e063-6294a90add76SPL ID 56a65e15-cd06-394c-e063-6294a90add76SPL set ID 5a504f74-bccd-433a-bd5b-6822f98c34dfRxCUI 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
N451672416403followed by a unit qualifier and the quantityPackage 51672-4164-03. 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 USP, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 51672-4164
- What is NDC 51672-4164?
- 51672-4164 is the product NDC for Metronidazole, Metronidazole 10 mg/g gel, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metronidazole.
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metronidazole?
- 160 other product NDCs are listed under this name. See all Metronidazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metronidazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4767 | 70518-4767-00 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-024 | 85742-0024-2485742-0024-25 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-025 | 85742-0025-2485742-0025-25 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2677 | 72162-2677-0172162-2677-0272162-2677-05 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2678 | 72162-2678-0172162-2678-0272162-2678-05 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1060 | 67046-1060-03 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1173 | 67046-1173-03 |
| Metronidazole | Metronidazole 7.5 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1978 | 70771-1978-04 |
| Metronidazole | Metronidazole 7.5 mg/g | GelTopical | Viona Pharmaceuticals Inc | 72578-209 | 72578-0209-04 |
| Metronidazole | Metronidazole 7.5 mg/g | GelVaginal | Solaris Pharma Corporation | 73473-303 | 73473-0303-70 |
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. | 51672-4215 |