Nitrofurantoin
- Product NDC
- 70954-496
- 11-digit product format
- 709540496
- Labeler code
- 70954
- Product ID
- 70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA216385
- Marketing category
- ANDA
- Marketing start
- 2023-04-17
- Substance
- NITROFURANTOIN
- 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 | 25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-496-10 | Nitrofurantoin | 230 mL in 1 BOTTLE | SUSPENSION | 230 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-496 | NITROFURANTOIN SUSPENSION [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, 1 package rows | 20241010_3b377aff-2d4b-43ea-84c9-8e72c1421b7b.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 |
|---|
| 70954-496-10 | 70954049610 | 230 mL in 1 BOTTLE (70954-496-10) | 230 ml | 2023-04-17 | No | No | Historical |