Prescription drug · ANDA
metronidazole NDC 72789-195
Metronidazole 250 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-195-06 | 72789019506 | 6 TABLET in 1 BOTTLE, PLASTIC (72789-195-06)Marketed from Oct 29, 2021 | |
| 72789-195-21 | 72789019521 | 21 TABLET in 1 BOTTLE, PLASTIC (72789-195-21)Marketed from Jun 30, 2021 | |
| 72789-195-30 | 72789019530 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-195-30)Marketed from Jun 30, 2021 |
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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206560
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 72789-195_40abd4b1-5378-c5b0-e063-6394a90af09dSPL ID 40abd4b1-5378-c5b0-e063-6394a90af09dSPL set ID 8f1de4ca-a005-4ca9-a43a-380429c80d6fRxCUI 314106UNII 140QMO216EUPC 0372789195308
- 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
N472789019506followed by a unit qualifier and the quantityPackage 72789-0195-06. 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 parasit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206560
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 | REMEDYREPACK INC. | 70518-3042 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-014 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2681 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-800 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-801 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Sportpharm LLC | 85766-024 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2409 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2663 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7815 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1703 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-539 |
| Metronidazole | Metronidazole 500 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1046 |
| metronidazole | Metronidazole 500 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-008 |
| Metronidazole | Metronidazole 250 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1045 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-007 |
| metronidazole | Metronidazole 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1775 |