NITROFURANTOIN
- Product NDC
- 70518-4244
- 11-digit product format
- 705184244
- Labeler code
- 70518
- Product ID
- 70518-4244_4007a97b-b1fb-3acf-e063-6394a90ad7a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NITROFURANTOIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211935
- Marketing category
- ANDA
- Marketing start
- 2024-12-20
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4244-0 | NITROFURANTOIN | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4244 | NITROFURANTOIN CAPSULE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20241225_87505f8f-2056-4e55-adf5-5b7309081d7c.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 |
|---|
| 70518-4244-0 | 70518424400 | 30 CAPSULE in 1 BLISTER PACK (70518-4244-0) | 30 capsule | 2024-12-20 | No | No | Historical |