Nitrofurantoin Macrocrystals
- Product NDC
- 0115-1645
- 11-digit product format
- 001151645
- Labeler code
- 0115
- Product ID
- 0115-1645_151534e1-3754-4da0-8fca-8ade53adca20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA073652
- Marketing category
- ANDA
- Marketing start
- 2007-03-08
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitrofurantoin Macrocrystals
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311995, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1645-01 | Nitrofurantoin Macrocrystals | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
| 0115-1645-03 | Nitrofurantoin Macrocrystals | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1645 | NITROFURANTOIN MACROCRYSTALS CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231231_341c75ac-fba5-480d-a221-868c4195cb6f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 536ed022-db80-492d-b6ab-809855ea90fb | 18 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 536ed022-db80-492d-b6ab-809855ea90fb | 18 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 341c75ac-fba5-480d-a221-868c4195cb6f | 15 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | PSN | 341c75ac-fba5-480d-a221-868c4195cb6f | 15 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 341c75ac-fba5-480d-a221-868c4195cb6f | 15 |
| 311995 | nitrofurantoin, macrocrystals 50 MG Oral Capsule | SCD | 341c75ac-fba5-480d-a221-868c4195cb6f | 15 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | SY | 341c75ac-fba5-480d-a221-868c4195cb6f | 15 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 650f3c60-d45d-4358-a388-7efee4ad0497 | 7 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | PSN | 650f3c60-d45d-4358-a388-7efee4ad0497 | 7 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 650f3c60-d45d-4358-a388-7efee4ad0497 | 7 |
| 311995 | nitrofurantoin, macrocrystals 50 MG Oral Capsule | SCD | 650f3c60-d45d-4358-a388-7efee4ad0497 | 7 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | SY | 650f3c60-d45d-4358-a388-7efee4ad0497 | 7 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | c335f76b-6b85-4c9f-bbfa-95514cdd80fa | 6 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | c335f76b-6b85-4c9f-bbfa-95514cdd80fa | 6 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 32520c80-0ce5-ea4b-e063-6294a90a37ba | 4 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 32520c80-0ce5-ea4b-e063-6294a90a37ba | 4 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | c87f65b9-14f7-4962-bff6-58b0d1af75f8 | 3 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | c87f65b9-14f7-4962-bff6-58b0d1af75f8 | 3 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1645-01 | 00115164501 | 100 CAPSULE in 1 BOTTLE (0115-1645-01) | 100 capsule | 2007-03-08 | 0000-00-00 | No | No | Current |
| 0115-1645-03 | 00115164503 | 1000 CAPSULE in 1 BOTTLE (0115-1645-03) | 1000 capsule | 2007-03-08 | 0000-00-00 | No | No | Current |