Nitrofurantoin
- Product NDC
- 70069-829
- 11-digit product format
- 700690829
- Labeler code
- 70069
- Product ID
- 70069-829_40efa147-f323-4d77-9a88-227434ff84c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA208909
- Marketing category
- ANDA
- Marketing start
- 2025-02-26
- Substance
- NITROFURANTOIN
- Active strength
- 25 mg/5mL
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], 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/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 |
|---|
| 70069-829-01 | Nitrofurantoin | 230 mL in 1 BOTTLE, GLASS | FOR SUSPENSION | 230 | | 3 |
| 70069-829-01 | Nitrofurantoin | 1 in 1 CARTON | FOR SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-829 | NITROFURANTOIN FOR SUSPENSION [SOMERSET THERAPEUTICS, LLC] | 1 | Current NDC, 2 package rows | 20250227_dd99ba40-edff-47c3-9ee4-7e5b7774e5b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-829-01 | 70069082901 | 1 BOTTLE, GLASS in 1 CARTON (70069-829-01) / 230 mL in 1 BOTTLE, GLASS | 2025-02-26 | No | No | Historical |