Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 68788-7092
- 11-digit product format
- 687887092
- Labeler code
- 68788
- Product ID
- 68788-7092_6cc953bd-c35e-4a55-aa7c-b980795b2c7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2018-02-12
- 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 |
|---|
| 68788-7092-0 | 68788709200 | 10 CAPSULE in 1 BOTTLE (68788-7092-0) | 10 capsule | 2019-11-07 | 0000-00-00 | No | No | Current |
| 68788-7092-1 | 68788709201 | 14 CAPSULE in 1 BOTTLE (68788-7092-1) | 14 capsule | 2018-02-12 | 0000-00-00 | No | No | Current |