Prescription drug · ANDA
Metronidazole NDC 62135-796
Metronidazole 500 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-796-90 | 62135079690 | 90 TABLET in 1 BOTTLE (62135-796-90)Marketed from Nov 7, 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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205245
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 62135-796_462a5456-eaf5-6f97-e063-6294a90ad050SPL ID 462a5456-eaf5-6f97-e063-6294a90ad050SPL set ID 40509b3c-b725-400c-abe5-d6d5714d405dRxCUI 311681, 314106UNII 140QMO216EUPC 0362135795900, 0362135796907
- 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
N462135079690followed by a unit qualifier and the quantityPackage 62135-0796-90. 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. Treatm…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205245
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 | Northwind Health Company, LLC | 51655-974 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-651 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Chartwell RX, LLC | 62135-795 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-652 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2251 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3265 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5283 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7126 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2343 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-441 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7156 |