Prescription drug · ANDA
Metronidazole NDC 50111-334
Metronidazole 500 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50111-334-01 | 50111033401 | 100 TABLET in 1 BOTTLE (50111-334-01)Marketed from Sep 30, 1990 | |
| 50111-334-02 | 50111033402 | 500 TABLET in 1 BOTTLE (50111-334-02)Marketed from Sep 30, 1990 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070033
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 50111-334_dece18c5-c8f0-4f76-9809-c9fd9d1905c1SPL ID dece18c5-c8f0-4f76-9809-c9fd9d1905c1SPL set ID 291a45f6-ed27-4dcc-8364-358d08623797RxCUI 311681, 314106UNII 140QMO216EUPC 0350111333017, 0350111334014
- 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
N450111033401followed by a unit qualifier and the quantityPackage 50111-0334-01. 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 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. Treatment…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070033
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 | REMEDYREPACK INC. | 70518-1240 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1241 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1386 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Redpharm Drug, inc. | 67296-0078 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Proficient Rx LP | 63187-035 |