Prescription drug · ANDA
metronidazole NDC 58657-933
Metronidazole 250 mg/1 · Tablet · Oral · Method Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-933-01 | 58657093301 | 100 BLISTER PACK in 1 CARTON (58657-933-01) / 1 TABLET in 1 BLISTER PACK (58657-933-10)Marketed from Jul 1, 2025 | |
| 58657-933-05 | 58657093305 | 50 BLISTER PACK in 1 CARTON (58657-933-05) / 1 TABLET in 1 BLISTER PACK (58657-933-10)Marketed from Jul 1, 2025 |
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
- Labeler
- Method Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070772
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 58657-933_51018185-a67f-bf2c-e063-6394a90adca5SPL ID 51018185-a67f-bf2c-e063-6394a90adca5SPL set ID 2ae49bf4-a23b-bdcc-e063-6294a90a80a9RxCUI 311681, 314106, 2702348UNII 140QMO216EUPC 0358657939038, 0358657739560, 0358657739010
- 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
N458657093301followed by a unit qualifier and the quantityPackage 58657-0933-01. 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 is 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 is 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. Treatment of Asymptomatic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070772
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 | Cardinal Health 107, LLC | 55154-8190 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | American Health Packaging | 60687-526 |
| metronidazole | Metronidazole 125 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2468 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | American Health Packaging | 60687-550 |
| metronidazole | Metronidazole 125 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-739 |
| metronidazole | Metronidazole 125 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2949 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-934 |
| metronidazole | Metronidazole 125 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-939 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-372 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-376 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | AMICI PHARMA INC | 69292-207 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | AMICI PHARMA INC | 69292-208 |