NITROFURANTOIN
- Product NDC
- 62332-389
- 11-digit product format
- 623320389
- Labeler code
- 62332
- Product ID
- 62332-389_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NITROFURANTOIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA211935
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- Substance
- NITROFURANTOIN
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311994, 311995, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-389-31 | NITROFURANTOIN | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 62332-389-91 | NITROFURANTOIN | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-389 | NITROFURANTOIN CAPSULE [ALEMBIC PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230513_a8a0d7d7-1e18-46a7-a1f8-e97499820035.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 |
|---|
| 62332-389-31 | 62332038931 | 100 CAPSULE in 1 BOTTLE (62332-389-31) | 100 capsule | 2021-07-01 | 0000-00-00 | No | No | Current |
| 62332-389-91 | 62332038991 | 1000 CAPSULE in 1 BOTTLE (62332-389-91) | 1000 capsule | 2021-07-01 | 0000-00-00 | No | No | Current |