Nitrofurantion
- Product NDC
- 57664-233
- 11-digit product format
- 576640233
- Labeler code
- 57664
- Product ID
- 57664-233_4ed13848-1151-c63a-e063-6394a90a3a05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantion
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201722
- Marketing category
- ANDA
- Marketing start
- 2016-04-15
- 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
- Nitrofurantion
- 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 | 311994, 311995, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-233-18 | Nitrofurantion | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 5 |
| 57664-233-88 | Nitrofurantion | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-233 | NITROFURANTION CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20190322_05f25774-f56a-48ef-bac3-8af663f8581a.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | eeb12928-61ab-42a0-a1fa-2819b9ffa3cb | 10 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | eeb12928-61ab-42a0-a1fa-2819b9ffa3cb | 10 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 43848e61-4d94-46f7-a610-93be927c8d16 | 5 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 870f64ca-0256-4e3f-8c34-dc603ccc41c0 | 5 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 311994 | nitrofurantoin macrocrystals 25 MG Oral Capsule | PSN | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | PSN | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 43848e61-4d94-46f7-a610-93be927c8d16 | 5 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 870f64ca-0256-4e3f-8c34-dc603ccc41c0 | 5 |
| 311994 | nitrofurantoin, macrocrystals 25 MG Oral Capsule | SCD | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 311995 | nitrofurantoin, macrocrystals 50 MG Oral Capsule | SCD | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 311994 | nitrofurantoin macrocrystals 25 MG Oral Capsule | SY | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | SY | 05f25774-f56a-48ef-bac3-8af663f8581a | 5 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | bd46cc46-0efa-d5d9-e053-2995a90a18f1 | 3 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | bd46cc46-0efa-d5d9-e053-2995a90a18f1 | 3 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | d8c68797-47a9-2956-e053-2a95a90a0149 | 1 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | d8c68797-47a9-2956-e053-2a95a90a0149 | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57664-233-18 | 57664023318 | 1000 CAPSULE in 1 BOTTLE (57664-233-18) | 1000 capsule | 2016-04-15 | 0000-00-00 | No | No | Current |
| 57664-233-88 | 57664023388 | 100 CAPSULE in 1 BOTTLE (57664-233-88) | 100 capsule | 2016-04-15 | 0000-00-00 | No | No | Current |