Nitrofurantoin
- Product NDC
- 65162-478
- 11-digit product format
- 651620478
- Labeler code
- 65162
- Product ID
- 65162-478_12c7ce84-65f3-4970-bdaf-b3c169294561
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin monohydrate/macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA207372
- Marketing category
- ANDA
- Marketing start
- 2017-05-25
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-478 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 19 | Legacy NDC | 20241031_55c75f27-b5fc-4f19-8607-08f8ec0c69ec.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 58614369-f5ac-4d38-9fb8-2383b791eb71 | 5 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 58614369-f5ac-4d38-9fb8-2383b791eb71 | 5 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f | 3 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 2bedff75-22c8-49cf-b2e6-8471fd69055c | 3 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f | 3 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 2bedff75-22c8-49cf-b2e6-8471fd69055c | 3 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 88de4809-bcbd-02ab-e053-2a95a90a4e88 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 88de4809-bcbd-02ab-e053-2a95a90a4e88 | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-478-10 | 65162047810 | 100 CAPSULE in 1 BOTTLE (65162-478-10) | 100 capsule | 2017-05-25 | 0000-00-00 | No | No | Current |