Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 71205-546
- 11-digit product format
- 712050546
- Labeler code
- 71205
- Product ID
- 71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-546 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [PROFICIENT RX LP] | 2 | Legacy NDC | 20220409_98c50178-3150-42a5-84f0-65b373f4978f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-546-10 | 71205054610 | 10 CAPSULE in 1 BOTTLE (71205-546-10) | 10 capsule | 2021-03-23 | 0000-00-00 | No | No | Current |
| 71205-546-14 | 71205054614 | 14 CAPSULE in 1 BOTTLE (71205-546-14) | 14 capsule | 2021-03-23 | 0000-00-00 | No | No | Current |
| 71205-546-20 | 71205054620 | 20 CAPSULE in 1 BOTTLE (71205-546-20) | 20 capsule | 2021-03-23 | 0000-00-00 | No | No | Current |
| 71205-546-30 | 71205054630 | 30 CAPSULE in 1 BOTTLE (71205-546-30) | 30 capsule | 2021-03-23 | 0000-00-00 | No | No | Current |
| 71205-546-60 | 71205054660 | 60 CAPSULE in 1 BOTTLE (71205-546-60) | 60 capsule | 2021-03-23 | 0000-00-00 | No | No | Current |
| 71205-546-90 | 71205054690 | 90 CAPSULE in 1 BOTTLE (71205-546-90) | 90 capsule | 2021-03-23 | 0000-00-00 | No | No | Current |