Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 70756-404
- 11-digit product format
- 707560404
- Labeler code
- 70756
- Product ID
- 70756-404_98c85803-fdee-41fa-af1a-98f05ef725d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lifestar Pharma LLC
- 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 |
|---|
| 70756-404-11 | Nitrofurantoin (monohydrate/macrocrystals) | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 70756-404-51 | Nitrofurantoin (monohydrate/macrocrystals) | 500 in 1 BOTTLE | CAPSULE | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-404 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [LIFESTAR PHARMA LLC] | 4 | Current NDC, 2 package rows | 20230914_35c0a6d8-ff85-4d9b-9ad3-ae20808119dd.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 | e55f3dc2-c754-4550-a2c0-c304471a8791 | 6 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | e55f3dc2-c754-4550-a2c0-c304471a8791 | 6 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | f49f586a-79f0-4731-97f9-9aeb0839ece5 | 4 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 35c0a6d8-ff85-4d9b-9ad3-ae20808119dd | 4 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | f49f586a-79f0-4731-97f9-9aeb0839ece5 | 4 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 35c0a6d8-ff85-4d9b-9ad3-ae20808119dd | 4 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 18987b15-6554-6b55-e063-6294a90a58d4 | 3 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 63a4b367-bf4b-4b5f-b3e9-394ba307886d | 3 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 63a4b367-bf4b-4b5f-b3e9-394ba307886d | 3 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 18987b15-6554-6b55-e063-6294a90a58d4 | 3 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 10e2503d-a250-996f-e063-6294a90abd61 | 2 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 155c8d68-576e-f85c-e063-6294a90ada4b | 2 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 11e8f91c-5712-4267-9956-e619d081d1f4 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 155c8d68-576e-f85c-e063-6294a90ada4b | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 11e8f91c-5712-4267-9956-e619d081d1f4 | 2 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 10e2503d-a250-996f-e063-6294a90abd61 | 2 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 513b514f-6e79-f187-e063-6394a90a07dc | 1 |
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 85c7d4ee-99f5-4324-a5fa-601c2fe664ab | 1 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 513b514f-6e79-f187-e063-6394a90a07dc | 1 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 85c7d4ee-99f5-4324-a5fa-601c2fe664ab | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70756-404-11 | 70756040411 | 100 CAPSULE in 1 BOTTLE (70756-404-11) | 100 capsule | 2023-09-14 | No | No | Current |
| 70756-404-51 | 70756040451 | 500 CAPSULE in 1 BOTTLE (70756-404-51) | 500 capsule | 2023-09-14 | No | No | Current |