NITROFURANTOIN
- Product NDC
- 31722-491
- 11-digit product format
- 317220491
- Labeler code
- 31722
- Product ID
- 31722-491_3c3bf8e0-5135-f295-e063-6294a90a7f67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NITROFURANTOIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA219495
- Marketing category
- ANDA
- Marketing start
- 2025-07-02
- 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 |
|---|
| 31722-491-23 | NITROFURANTOIN | 230 mL in 1 BOTTLE | SUSPENSION | 230 | | 1 |
| 31722-491-23 | NITROFURANTOIN | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-491-23 | 31722049123 | 1 BOTTLE in 1 CARTON (31722-491-23) / 230 mL in 1 BOTTLE | 1 bottle | 2025-07-02 | No | No | Historical |