Nitrofurantoin
- Product NDC
- 70518-3717
- 11-digit product format
- 705183717
- Labeler code
- 70518
- Product ID
- 70518-3717_4f80c423-d0ae-4468-e063-6294a90a9041
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208516
- Marketing category
- ANDA
- Marketing start
- 2023-04-18
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitrofurantoin
- Listing expiration
- 2027-12-31
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 |
|---|
| 70518-3717-0 | Nitrofurantoin | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 9 |
| 70518-3717-1 | Nitrofurantoin | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 9 |
| 70518-3717-2 | Nitrofurantoin | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 9 |
| 70518-3717-3 | Nitrofurantoin | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3717 | NITROFURANTOIN CAPSULE [REMEDYREPACK INC.] | 6 | Current NDC, 4 package rows | 20240329_6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3717-0 | 70518371700 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3717-0) | 14 capsule | 2023-04-18 | No | No | Historical |
| 70518-3717-1 | 70518371701 | 30 in 1 BLISTER PACK | | | | | Historical |
| 70518-3717-2 | 70518371702 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3717-2) | 10 capsule | 2023-09-02 | No | No | Historical |
| 70518-3717-3 | 70518371703 | 20 in 1 BOTTLE, PLASTIC | | | | | Historical |