Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 68071-3163
- 11-digit product format
- 680713163
- Labeler code
- 68071
- Product ID
- 68071-3163_4aa03876-8a17-55f6-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare 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
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record