Nitrofurantoin
- Product NDC
- 42571-393
- 11-digit product format
- 425710393
- Labeler code
- 42571
- Product ID
- 42571-393_35155f61-5d28-d364-e063-6294a90aa4c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA217073
- Marketing category
- ANDA
- Marketing start
- 2024-04-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitrofurantoin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 1648755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-393-01 | Nitrofurantoin | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 42571-393-05 | Nitrofurantoin | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
| 42571-393-90 | Nitrofurantoin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-393 | NITROFURANTOIN CAPSULE [MICRO LABS LIMITED] | 2 | Current NDC, 3 package rows | 20250515_d96098d0-3c2b-4e53-a3f0-3ebba81c4133.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-393-01 | 42571039301 | 100 CAPSULE in 1 BOTTLE (42571-393-01) | 100 capsule | 2024-04-01 | No | No | Current |
| 42571-393-05 | 42571039305 | 500 CAPSULE in 1 BOTTLE (42571-393-05) | 500 capsule | 2024-04-01 | No | No | Current |
| 42571-393-90 | 42571039390 | 90 CAPSULE in 1 BOTTLE (42571-393-90) | 90 capsule | 2024-04-01 | No | No | Current |