Nitrofurantoin
- Product NDC
- 63629-9191
- 11-digit product format
- 636299191
- Labeler code
- 63629
- Product ID
- 63629-9191_310440b5-800a-44ad-9f26-24860f30a08b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208516
- Marketing category
- ANDA
- Marketing start
- 2018-01-01
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-9191-1 | 63629919101 | 100 CAPSULE in 1 BOTTLE (63629-9191-1) | 100 capsule | 2022-08-15 | 0000-00-00 | No | No | Current |