nitrofurantoin
- Product NDC
- 71335-1069
- 11-digit product format
- 713351069
- Labeler code
- 71335
- Product ID
- 71335-1069_05e89273-b886-40bb-be42-7807d29f5dee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205005
- Marketing category
- ANDA
- Marketing start
- 2018-02-15
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1069-1 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-2 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-3 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-4 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-5 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-6 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-7 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-8 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-9 | 2024-05-20 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-7 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
| 71335-1069-9 | 2024-01-30 | C162847 | 48780-1 | 1030e365-518e-111a-e063-dadaa90a10e2 | Nitrofurantoin Capsules, USP (Macrocrystals) Rx only |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1069 | NITROFURANTOIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 9 package rows | 20240522_aca04d52-8a64-4fca-94b2-64b46f5a3218.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 |
|---|
| 71335-1069-1 | 71335106901 | 40 CAPSULE in 1 BOTTLE (71335-1069-1) | 40 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1069-2 | 71335106902 | 28 CAPSULE in 1 BOTTLE (71335-1069-2) | 28 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1069-3 | 71335106903 | 30 CAPSULE in 1 BOTTLE (71335-1069-3) | 30 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1069-4 | 71335106904 | 20 CAPSULE in 1 BOTTLE (71335-1069-4) | 20 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1069-5 | 71335106905 | 14 CAPSULE in 1 BOTTLE (71335-1069-5) | 14 capsule | 2019-01-21 | 0000-00-00 | No | No | Current |
| 71335-1069-6 | 71335106906 | 10 CAPSULE in 1 BOTTLE (71335-1069-6) | 10 capsule | 2019-02-25 | 0000-00-00 | No | No | Current |
| 71335-1069-7 | 71335106907 | 12 CAPSULE in 1 BOTTLE (71335-1069-7) | 12 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1069-8 | 71335106908 | 90 CAPSULE in 1 BOTTLE (71335-1069-8) | 90 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1069-9 | 71335106909 | 6 CAPSULE in 1 BOTTLE (71335-1069-9) | 6 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |