nitrofurantoin macrocrystals
- Product NDC
- 70518-3827
- 11-digit product format
- 705183827
- Labeler code
- 70518
- Product ID
- 70518-3827_3f66ecaf-4520-5734-e063-6294a90aecaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA217272
- Marketing category
- ANDA
- Marketing start
- 2023-08-12
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 927AH8112L | NITROFURANTOIN | 67-20-9 | NITROFURANTOIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3827-0 | 70518382700 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-0) | 14 capsule | 2023-08-12 | No | No | Historical |
| 70518-3827-1 | 70518382701 | 6 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-1) | 6 capsule | 2025-01-28 | No | No | Historical |
| 70518-3827-2 | 70518382702 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-2) | 10 capsule | 2025-01-30 | No | No | Historical |