Nitrofurantoin Macrocrystals
- Product NDC
- 68071-2517
- 11-digit product format
- 680712517
- Labeler code
- 68071
- Product ID
- 68071-2517_ca56360b-c128-b093-e053-2995a90ace1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA073652
- Marketing category
- ANDA
- Marketing start
- 2007-03-08
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-2517-2 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-6 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-7 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-8 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-2 | 2023-05-19 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-6 | 2023-05-19 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-7 | 2023-05-19 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-8 | 2023-05-19 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-6 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-7 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 68071-2517-8 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2f57-0266-e053-dadaa90a7c1a | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2517-2 | Nitrofurantoin Macrocrystals | 20 in 1 BOTTLE | CAPSULE | 20 | | 2 |
| 68071-2517-6 | Nitrofurantoin Macrocrystals | 6 in 1 BOTTLE | CAPSULE | 6 | | 2 |
| 68071-2517-7 | Nitrofurantoin Macrocrystals | 14 in 1 BOTTLE | CAPSULE | 14 | | 2 |
| 68071-2517-8 | Nitrofurantoin Macrocrystals | 28 in 1 BOTTLE | CAPSULE | 28 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2517 | NITROFURANTOIN MACROCRYSTALS CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC, 4 package rows | 20230520_ca55d17a-6491-c495-e053-2a95a90a6845.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2517-2 | 68071251702 | 20 CAPSULE in 1 BOTTLE (68071-2517-2) | 20 capsule | 2021-08-24 | 0000-00-00 | No | No | Current |
| 68071-2517-6 | 68071251706 | 6 CAPSULE in 1 BOTTLE (68071-2517-6) | 6 capsule | 2021-08-24 | 0000-00-00 | No | No | Current |
| 68071-2517-7 | 68071251707 | 14 CAPSULE in 1 BOTTLE (68071-2517-7) | 14 capsule | 2021-08-24 | 0000-00-00 | No | No | Current |
| 68071-2517-8 | 68071251708 | 28 CAPSULE in 1 BOTTLE (68071-2517-8) | 28 capsule | 2021-08-24 | 0000-00-00 | No | No | Current |