Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 68071-3593
- 11-digit product format
- 680713593
- Labeler code
- 68071
- Product ID
- 68071-3593_45a09574-d7e4-1932-e063-6394a90a8765
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA217357
- Marketing category
- ANDA
- Marketing start
- 2023-09-14
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25; 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], 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 (monohydrate/macrocrystals)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 25 mg/1 |
| NITROFURANTOIN MONOHYDRATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L, E1QI2CQQ1I |
| Rxcui | 1648755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3593-2 | Nitrofurantoin (monohydrate/macrocrystals) | 2 in 1 BOTTLE | CAPSULE | 2 | | 2 |
| 68071-3593-6 | Nitrofurantoin (monohydrate/macrocrystals) | 6 in 1 BOTTLE | CAPSULE | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3593 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 2 package rows | 20240406_155c8d68-576e-f85c-e063-6294a90ada4b.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 |
|---|
| 68071-3593-2 | 68071359302 | 2 CAPSULE in 1 BOTTLE (68071-3593-2) | 2 capsule | 2025-12-10 | No | No | Historical |
| 68071-3593-6 | 68071359306 | 6 CAPSULE in 1 BOTTLE (68071-3593-6) | 6 capsule | 2024-04-05 | No | No | Historical |