METRONIDAZOLE
- Product NDC
- 59651-813
- 11-digit product format
- 596510813
- Labeler code
- 59651
- Product ID
- 59651-813_d9d4caed-2fa9-4b46-9b7c-d60ec3b879b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METRONIDAZOLE
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA218941
- Marketing category
- ANDA
- Marketing start
- 2024-10-15
- Substance
- METRONIDAZOLE
- Active strength
- 10 mg/g
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-813-60 | 59651081360 | 1 TUBE in 1 CARTON (59651-813-60) / 60 g in 1 TUBE | 1 tube | 2024-10-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METRONIDAZOLE | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2024-10-17 | Human Prescription Drug Label | 1 |