Metronidazole
- Product NDC
- 68788-8674
- 11-digit product format
- 687888674
- Labeler code
- 68788
- Product ID
- 68788-8674_57a2ffa7-f812-4e00-8787-260b705cd8bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA203458
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 140QMO216E | METRONIDAZOLE | 443-48-1 | METRONIDAZOLE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8674-1 | 68788867401 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-1) | 2024-05-23 | No | No | Historical |
| 68788-8674-2 | 68788867402 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-2) | 2024-05-23 | No | No | Historical |
| 68788-8674-3 | 68788867403 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-3) | 2024-05-23 | No | No | Historical |
| 68788-8674-4 | 68788867404 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-4) | 2024-05-23 | No | No | Historical |
| 68788-8674-5 | 68788867405 | 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-5) | 2024-05-23 | No | No | Historical |
| 68788-8674-7 | 68788867407 | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-7) | 2024-05-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metronidazole Tablets USP | Preferred Pharmaceuticals Inc. | 2025-08-11 | HUMAN PRESCRIPTION DRUG LABEL | 2 |