Prescription drug · ANDA
Metronidazole NDC 63629-1386
Metronidazole 500 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1386-0 | 63629138600 | 40 TABLET in 1 BOTTLE (63629-1386-0)Marketed from Aug 3, 2010 | |
| 63629-1386-1 | 63629138601 | 20 TABLET in 1 BOTTLE (63629-1386-1)Marketed from Dec 16, 2004 | |
| 63629-1386-2 | 63629138602 | 30 TABLET in 1 BOTTLE (63629-1386-2)Marketed from Dec 20, 2004 | |
| 63629-1386-3 | 63629138603 | 14 TABLET in 1 BOTTLE (63629-1386-3)Marketed from Mar 26, 2007 | |
| 63629-1386-4 | 63629138604 | 56 TABLET in 1 BOTTLE (63629-1386-4)Marketed from Aug 10, 2006 | |
| 63629-1386-5 | 63629138605 | 21 TABLET in 1 BOTTLE (63629-1386-5)Marketed from Feb 12, 2009 | |
| 63629-1386-6 | 63629138606 | 4 TABLET in 1 BOTTLE (63629-1386-6)Marketed from Jun 12, 2008 | |
| 63629-1386-7 | 63629138607 | 28 TABLET in 1 BOTTLE (63629-1386-7)Marketed from Jul 7, 2008 | |
| 63629-1386-8 | 63629138608 | 100 TABLET in 1 BOTTLE (63629-1386-8)Marketed from Aug 26, 2010 | |
| 63629-1386-9 | 63629138609 | 60 TABLET in 1 BOTTLE (63629-1386-9)Marketed from Mar 8, 2022 |
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
- Bryant Ranch Prepack
- 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 63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27caSPL ID 7a0f2236-cf51-409f-94f9-ce62135b27caSPL set ID e1e7e127-e99e-80e9-1606-71261658b0c1RxCUI 311681UNII 140QMO216E
- 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
N463629138600followed by a unit qualifier and the quantityPackage 63629-1386-00. 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 | Redpharm Drug, inc. | 67296-0078 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Proficient Rx LP | 63187-035 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 50111-334 |