Nitrofurantion
- Product NDC
- 68071-2363
- 11-digit product format
- 680712363
- Labeler code
- 68071
- Product ID
- 68071-2363_4b353a66-abe4-a233-e063-6294a90a685d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantion
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA201722
- Marketing category
- ANDA
- Marketing start
- 2016-04-15
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- 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
- Nitrofurantion
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-2363-7 | 2025-01-10 | C162847 | 48780-1 | f386c649-bf17-0266-e053-dadaa90a7c1a | Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only |
| 68071-2363-8 | 2025-01-10 | C162847 | 48780-1 | f386c649-bf17-0266-e053-dadaa90a7c1a | Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only |
| 68071-2363-7 | 2023-01-30 | C162847 | 48780-1 | f386c649-bf17-0266-e053-dadaa90a7c1a | Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only |
| 68071-2363-8 | 2023-01-30 | C162847 | 48780-1 | f386c649-bf17-0266-e053-dadaa90a7c1a | Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2363-7 | Nitrofurantion | 14 in 1 BOTTLE | CAPSULE | 14 | | 3 |
| 68071-2363-8 | Nitrofurantion | 28 in 1 BOTTLE | CAPSULE | 28 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2363 | NITROFURANTION CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250112_bd46cc46-0efa-d5d9-e053-2995a90a18f1.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 |
|---|
| 68071-2363-7 | 68071236307 | 14 CAPSULE in 1 BOTTLE (68071-2363-7) | 14 capsule | 2021-03-11 | 0000-00-00 | No | No | Current |
| 68071-2363-8 | 68071236308 | 28 CAPSULE in 1 BOTTLE (68071-2363-8) | 28 capsule | 2021-03-11 | 0000-00-00 | No | No | Current |