NITROFURANTOIN (monohydrate/macrocrystals)
- Product NDC
- 59746-762
- 11-digit product format
- 597460762
- Labeler code
- 59746
- Product ID
- 59746-762_2096b57d-b4dd-568f-e063-6294a90a830d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA211013
- Marketing category
- ANDA
- Marketing start
- 2022-02-22
- 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 |
|---|
| 59746-762-01 | NITROFURANTOIN (monohydrate/macrocrystals) | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 59746-762-36 | NITROFURANTOIN (monohydrate/macrocrystals) | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 7 |
| 59746-762-06 | NITROFURANTOIN (monohydrate/macrocrystals) | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 59746-762-15 | NITROFURANTOIN (monohydrate/macrocrystals) | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-762 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240829_266824c7-7e9f-4c5f-b642-3bb7bf1c4fe6.zip |
| 59746-762 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20240813_1f7a9414-5592-f2ca-e063-6394a90a75f4.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 | 266824c7-7e9f-4c5f-b642-3bb7bf1c4fe6 | 7 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 266824c7-7e9f-4c5f-b642-3bb7bf1c4fe6 | 7 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 055477be-e42c-fe8b-e063-6394a90a0449 | 5 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 055477be-e42c-fe8b-e063-6394a90a0449 | 5 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 25172572-dbdc-db70-e063-6394a90aa87b | 4 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 25172572-dbdc-db70-e063-6394a90aa87b | 4 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | b6c5bbb0-86db-4a76-a1eb-98573a0b0adc | 3 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 2a772eb3-4fb3-4d92-b9f4-469dd2216361 | 3 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 2a772eb3-4fb3-4d92-b9f4-469dd2216361 | 3 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | b6c5bbb0-86db-4a76-a1eb-98573a0b0adc | 3 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 3dd034a6-8810-93f5-e063-6394a90a36c2 | 2 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 1f7a9414-5592-f2ca-e063-6394a90a75f4 | 2 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | d1825b58-2c00-475d-8d9b-cc07c66383f5 | 2 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | ee3f300a-d6d3-49c4-bd60-425f04d30b88 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 3dd034a6-8810-93f5-e063-6394a90a36c2 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 1f7a9414-5592-f2ca-e063-6394a90a75f4 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | d1825b58-2c00-475d-8d9b-cc07c66383f5 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | ee3f300a-d6d3-49c4-bd60-425f04d30b88 | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-762-01 | 59746076201 | 100 CAPSULE in 1 BOTTLE (59746-762-01) | 100 capsule | 2022-02-22 | 0000-00-00 | No | No | Current |
| 59746-762-06 | 59746076206 | 100 CAPSULE in 1 BOTTLE (59746-762-06) | 100 capsule | 2024-08-07 | | No | No | Current |
| 59746-762-15 | 59746076215 | 1000 CAPSULE in 1 BOTTLE (59746-762-15) | 1000 capsule | 2024-08-07 | | No | No | Current |
| 59746-762-36 | 59746076236 | 1000 CAPSULE in 1 BOTTLE (59746-762-36) | 1000 capsule | 2022-02-22 | 0000-00-00 | No | No | Current |