Prescription drug · ANDA
Metronidazole NDC 68071-2399
Metronidazole 500 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2399-4 | 68071239904 | 4 TABLET in 1 BOTTLE (68071-2399-4)Marketed from May 12, 2021 | |
| 68071-2399-6 | 68071239906 | 6 TABLET in 1 BOTTLE (68071-2399-6)Marketed from May 12, 2021 |
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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203974
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 68071-2399_4cecacbc-1f33-c0b5-e063-6394a90aeb33SPL ID 4cecacbc-1f33-c0b5-e063-6394a90aeb33SPL set ID c225a455-ec25-2213-e053-2995a90a3389RxCUI 311681UNII 140QMO216EUPC 0368071239942
- 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
N468071239904followed by a unit qualifier and the quantityPackage 68071-2399-04. 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 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 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 parasite. Treatme…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203974
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 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-694 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-695 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3110 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1838 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-664 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-665 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1922 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-5691 |