Nitrofurantoin
- Product NDC
- 72789-386
- 11-digit product format
- 727890386
- Labeler code
- 72789
- Product ID
- 72789-386_40c03d65-8d08-371a-e063-6294a90a7ac6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA208516
- Marketing category
- ANDA
- Marketing start
- 2018-01-01
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25; 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [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 |
|---|
| 927AH8112L | NITROFURANTOIN | 67-20-9 | NITROFURANTOIN |
| E1QI2CQQ1I | NITROFURANTOIN MONOHYDRATE | 17140-81-7 | NITROFURANTOIN MONOHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-386-06 | 72789038606 | 6 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-06) | 6 capsule | 2024-04-03 | No | No | Historical |
| 72789-386-10 | 72789038610 | 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-10) | 10 capsule | 2024-02-27 | No | No | Historical |
| 72789-386-14 | 72789038614 | 14 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-14) | 14 capsule | 2024-02-27 | No | No | Historical |