Nitrofurantoin Monohydrate/Macrocrystalline
- Product NDC
- 68001-001
- 11-digit product format
- 680010001
- Labeler code
- 68001
- Product ID
- 68001-001_1615769a-b731-4deb-a027-2df368cc2625
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2013-03-20
- Marketing end
- 2021-05-31
- 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
- 0000-00-00
- 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 |
|---|
| 68001-001-00 | 68001000100 | 100 CAPSULE in 1 BOTTLE (68001-001-00) | 100 capsule | 2013-03-20 | 2021-05-31 | No | No | Current |