Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 55289-822
- 11-digit product format
- 552890822
- Labeler code
- 55289
- Product ID
- 55289-822_e717fffb-b93d-7a48-e053-2995a90a4b6e
- 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 |
|---|
| 55289-822-02 | 55289082202 | 2 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-02) | 2 capsule | 2014-12-04 | 0000-00-00 | No | No | Current |
| 55289-822-06 | 55289082206 | 6 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-06) | 6 capsule | 2014-12-04 | 0000-00-00 | No | No | Current |
| 55289-822-10 | 55289082210 | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-10) | 10 capsule | 2014-12-04 | 0000-00-00 | No | No | Current |
| 55289-822-14 | 55289082214 | 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-14) | 14 capsule | 2014-12-04 | 0000-00-00 | No | No | Current |
| 55289-822-20 | 55289082220 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-20) | 20 capsule | 2014-12-04 | 0000-00-00 | No | No | Current |