Prescription drug · ANDA
Metronidazole NDC 43063-719
Metronidazole 250 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-719-06 | 43063071906 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-06)Marketed from Nov 2, 2016 | |
| 43063-719-21 | 43063071921 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-21)Marketed from May 1, 2017 | |
| 43063-719-28 | 43063071928 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-28)Marketed from May 3, 2017 | |
| 43063-719-30 | 43063071930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-30)Marketed from Oct 24, 2016 | |
| 43063-719-56 | 43063071956 | 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-56)Marketed from Apr 5, 2018 |
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, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203458
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 43063-719_414af257-be78-1935-e063-6394a90a7b1aSPL ID 414af257-be78-1935-e063-6394a90a7b1aSPL set ID 353b7f5b-4bbc-4ec9-84ba-d82656ea1811RxCUI 314106UNII 140QMO216EUPC 0343063719213
- 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
N443063071906followed by a unit qualifier and the quantityPackage 43063-0719-06. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 203458
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 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-005 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-1876 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-6960 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2640 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3039 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0358 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 61919-032 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2305 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-226 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-227 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2280 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-740 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-745 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1388 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-827 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2152 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8674 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1536 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1060 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-298 |
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