Prescription drug · ANDA
metronidazole NDC 82868-014
Metronidazole 500 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82868-014-14 | 8286800141482868001414 | 14 TABLET in 1 BOTTLE, PLASTIC (82868-014-14)Marketed from Sep 28, 2023 | |
| 82868-014-20 | 8286800142082868001420 | 20 TABLET in 1 BOTTLE, PLASTIC (82868-014-20)Marketed from Aug 12, 2024 | |
| 82868-014-21 | 8286800142182868001421 | 21 TABLET in 1 BOTTLE, PLASTIC (82868-014-21)Marketed from Feb 5, 2024 | |
| 82868-014-28 | 8286800142882868001428 | 28 TABLET in 1 BOTTLE, PLASTIC (82868-014-28)Marketed from Oct 4, 2023 | |
| 82868-014-30 | 8286800143082868001430 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-014-30)Marketed from Nov 30, 2023 |
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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 82868
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206560
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 82868-014_483491f2-bd96-dcd7-e063-6394a90a475dSPL ID 483491f2-bd96-dcd7-e063-6394a90a475dSPL set ID 06bd4afb-4a45-294c-e063-6394a90a7ab1RxCUI 311681UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482868001414followed by a unit qualifier and the quantityPackage 82868-0014-14. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets, USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets, USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasit…
Excerpt only. Read the full label for complete information.
About NDC 82868-014
- What is NDC 82868-014?
- 82868-014 is the product NDC for metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 5 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?
- Northwind Health Company, LLC, NDC labeler code 82868. 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 206560
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 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1703 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3042 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1045 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-195 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1046 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1775 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Sportpharm LLC | 85766-024 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-007 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-008 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2681 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-800 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-801 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2409 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2663 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7815 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-539 |