Nitrofurantoin
- Product NDC
- 53002-7041
- 11-digit product format
- 530027041
- Labeler code
- 53002
- Product ID
- 53002-7041_42f492a4-ff3d-4f8c-bb09-6e0eb3f6e57e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2005-04-06
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
- Active strength
- 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-7041-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-4 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-1 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-2 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-3 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-4 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-4 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-3 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-4 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
| 53002-7041-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c6cd-f424-e053-dadaa90a57ce | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-7041-1 | Nitrofurantoin | 6 in 1 BOTTLE | CAPSULE | 6 | | 5 |
| 53002-7041-2 | Nitrofurantoin | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
| 53002-7041-3 | Nitrofurantoin | 14 in 1 BOTTLE | CAPSULE | 14 | | 5 |
| 53002-7041-4 | Nitrofurantoin | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-7041 | NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_393219f6-580c-4fc5-87c8-c8506380da7b.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 |
|---|
| 53002-7041-1 | 53002704101 | 6 CAPSULE in 1 BOTTLE (53002-7041-1) | 6 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7041-2 | 53002704102 | 10 CAPSULE in 1 BOTTLE (53002-7041-2) | 10 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7041-3 | 53002704103 | 14 CAPSULE in 1 BOTTLE (53002-7041-3) | 14 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7041-4 | 53002704104 | 20 CAPSULE in 1 BOTTLE (53002-7041-4) | 20 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |