nitrofurantoin (macrocrystals)
- Product NDC
- 59651-942
- 11-digit product format
- 596510942
- Labeler code
- 59651
- Product ID
- 59651-942_04053ba5-ceb5-4f34-9878-8abf1e552da2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin (macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077025
- Marketing category
- ANDA
- Marketing start
- 2024-10-02
- Substance
- NITROFURANTOIN
- Active strength
- 25 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 (macrocrystals)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311994, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-942-01 | nitrofurantoin (macrocrystals) | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-942 | NITROFURANTOIN (MACROCRYSTALS) CAPSULE [AUROBINDO PHARMA LIMITED] | 3 | Current NDC, 1 package rows | 20241012_b2fc8354-b413-4c9d-88ec-ccc43d059d51.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 |
|---|
| 59651-942-01 | 59651094201 | 100 CAPSULE in 1 BOTTLE (59651-942-01) | 100 capsule | 2024-10-02 | No | No | Historical |