Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 68788-0518
- 11-digit product format
- 687880518
- Labeler code
- 68788
- Product ID
- 68788-0518_0a0a22cf-3281-44d4-ac57-e875bb17c94b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2014-02-13
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 68788-0518-0 | 68788051800 | 10 CAPSULE in 1 BOTTLE (68788-0518-0) | 10 capsule | 2019-11-07 | 0000-00-00 | No | No | Current |
| 68788-0518-1 | 68788051801 | 14 CAPSULE in 1 BOTTLE (68788-0518-1) | 14 capsule | 2014-02-13 | 0000-00-00 | No | No | Current |