Nitrofurantoin
- Product NDC
- 59651-206
- 11-digit product format
- 596510206
- Labeler code
- 59651
- Product ID
- 59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA212607
- Marketing category
- ANDA
- Marketing start
- 2023-05-11
- Substance
- NITROFURANTOIN MONOHYDRATE
- Active strength
- 25 mg/5mL
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN MONOHYDRATE | 25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E1QI2CQQ1I |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-206-23 | Nitrofurantoin | 230 mL in 1 BOTTLE | SUSPENSION | 230 | | 2 |
| 59651-206-23 | Nitrofurantoin | 1 in 1 CARTON | SUSPENSION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-206 | NITROFURANTOIN SUSPENSION [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 2 package rows | 20240330_e9d10eaa-cf9c-469e-82ef-5af7285f2c86.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-206-23 | 59651020623 | 1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE | 1 bottle | 2023-05-11 | No | No | Historical |