Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 43063-582
- 11-digit product format
- 430630582
- Labeler code
- 43063
- Product ID
- 43063-582_e68acc1e-a022-855c-e053-2a95a90a9523
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2011-05-25
- 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 |
|---|
| 43063-582-10 | 43063058210 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-582-10) | 10 capsule | 2020-02-10 | 0000-00-00 | No | No | Current |
| 43063-582-14 | 43063058214 | 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-582-14) | 14 capsule | 2012-06-07 | 0000-00-00 | No | No | Current |