Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 0480-3470
- 11-digit product format
- 004803470
- Labeler code
- 0480
- Product ID
- 0480-3470_e0c4eedf-9037-4fc5-9844-2e40d58f123b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2022-09-09
- 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 |
|---|
| 0480-3470-01 | 00480347001 | 100 CAPSULE in 1 BOTTLE (0480-3470-01) | 100 capsule | 2022-09-09 | 0000-00-00 | No | No | Current |