Application 209387
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 50MG/100ML (0.5MG/ML) | Yes | Yes |
| 002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 10MG/50ML (0.2MG/ML) | Yes | No |
| 003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 |
| N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | |
| N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N209387-001 | AP |
| N209387-003 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209387-002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2017-12-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209387-003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 20MG/100ML (0.2MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2018-07-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209387-001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 50MG/100ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-03-08 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209387-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209387-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209387-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209387-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209387-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209387-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209387-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209387-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209387-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209387-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209387-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209387-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209387-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209387-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209387-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209387-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209387-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209387-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209387-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209387-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209387-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209387-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209387-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209387-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209387-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209387-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209387-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N209387-003 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209387-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209387-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N209387-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N209387-003 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N209387-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N209387-003 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209387-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209387-003 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209387-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209387-003 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209387-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209387-003 | AP | 1 | a67488948f0b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NIPRIDE RTU | SODIUM NITROPRUSSIDE | EXELA PHARMA SCIENCES, LLC | 5acf0836-93ff-4064-b888-3f560e8a558d | 2018-07-20 | Boxed warning, Warnings, Adverse reactions | 209387 NDA209387 51754-1006 51754-1018 51754-1029 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51754-1006 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1006 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1018 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1018 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1029 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1029 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |