Nitrofurantoin
- Product NDC
- 65162-689
- 11-digit product format
- 651620689
- Labeler code
- 65162
- Product ID
- 65162-689_96cbbaac-bd28-443c-bc4c-967fa09a2f99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA201679
- Marketing category
- ANDA
- Marketing start
- 2011-03-24
- 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 |
|---|
| 65162-689-88 | Nitrofurantoin | 230 mL in 1 BOTTLE, GLASS | SUSPENSION | 230 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-689 | NITROFURANTOIN SUSPENSION [AMNEAL PHARMACEUTICALS LLC] | 16 | Current NDC, Legacy NDC, 1 package rows | 20241031_11dcea9c-0c62-4153-976b-bd1f8ef1f6d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-689-88 | 65162068988 | 230 mL in 1 BOTTLE, GLASS (65162-689-88) | 230 ml | 2011-03-24 | 0000-00-00 | No | No | Current |