Nitrofurantoin
- Product NDC
- 16571-888
- 11-digit product format
- 165710888
- Labeler code
- 16571
- Product ID
- 16571-888_b6694787-d7b8-4bcb-8dff-5ff30a83443a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- NDA009175
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-02-01
- Substance
- NITROFURANTOIN
- Active strength
- 50 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 | 50 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311989, 422434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-888-06 | Nitrofurantoin | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 5 |
| 16571-888-06 | Nitrofurantoin | 1 in 1 CARTON | SUSPENSION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-888 | NITROFURANTOIN SUSPENSION [RISING PHARMA HOLDINGS, INC.] | 4 | Current NDC, 2 package rows | 20240406_89095f4d-e142-465e-b378-da24f6eeaf2b.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 |
|---|
| 16571-888-06 | 16571088806 | 1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE | 1 bottle | 2024-02-01 | No | No | Historical |