Prescription drug · ANDA
Metronidazole NDC 60687-550
Metronidazole 500 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-550-01 | 60687055001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-550-01) / 1 TABLET in 1 BLISTER PACK (60687-550-11)Marketed from Mar 20, 2020 |
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
- American Health Packaging
- 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 60687-550_47e7b4dd-b3b2-f6a0-e063-6294a90a1bcaSPL ID 47e7b4dd-b3b2-f6a0-e063-6294a90a1bcaSPL set ID c90da73c-e48e-411a-bd75-0b107f1141ccRxCUI 311681, 314106UNII 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
N460687055001followed by a unit qualifier and the quantityPackage 60687-0550-01. 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, USP 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, USP 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.…
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 125 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-739 |
| metronidazole | Metronidazole 125 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2949 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-933 |
| 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 |