Prescription drug · ANDA
Metronidazole NDC 46708-428
Metronidazole 250 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-428-30 | 46708042830 | 30 TABLET in 1 BOTTLE (46708-428-30)Marketed from Dec 1, 2016 | |
| 46708-428-31 | 46708042831 | 100 TABLET in 1 BOTTLE (46708-428-31)Marketed from Dec 1, 2016 | |
| 46708-428-50 | 46708042850 | 50 TABLET in 1 BOTTLE (46708-428-50)Marketed from Dec 1, 2016 | |
| 46708-428-61 | 46708042861 | 250 TABLET in 1 BOTTLE (46708-428-61)Marketed from Dec 1, 2016 | |
| 46708-428-71 | 46708042871 | 500 TABLET in 1 BOTTLE (46708-428-71)Marketed from Dec 1, 2016 | |
| 46708-428-91 | 46708042891 | 1000 TABLET in 1 BOTTLE (46708-428-91)Marketed from Dec 1, 2016 |
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 — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079067
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9SPL ID 68765ffa-e238-40bb-8235-4ae53fb292e9SPL set ID d7455566-16aa-488a-af2a-93b55a04c02fRxCUI 311681, 314106UNII 140QMO216EUPC 0346708429300, 0346708428303
- 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
N446708042830followed by a unit qualifier and the quantityPackage 46708-0428-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 079067
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 | PD-Rx Pharmaceuticals, Inc. | 72789-007 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5073 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | AvPAK | 50268-534 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | AvPAK | 50268-535 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2288 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-011 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-016 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-017 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1681 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-429 |