Application 019217
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/ML | Yes | No |
| 002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 45MG/5ML (9MG/ML) | Yes | No |
| 003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 90MG/10ML (9MG/ML) | Yes | No |
| 004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 360MG/40ML (9MG/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | |
| N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | |
| N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | |
| N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019217-001 | SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1984-07-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019217-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 45MG/5ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019217-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1998-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019217-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 360MG/40ML (9MG/ML) | SOLUTION / INJECTION | RLD | 1999-04-01 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| 0.9% SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c755e41b-acba-7234-e053-2995a90aff0f | 2021-07-17 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 4a655cde-283f-4ec8-a3d9-5f539c55c204 | 2021-05-10 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ed8fd0c1-ac42-4267-877e-ceadf3831c90 | 2021-04-29 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | c3f8e83c-4fb9-91da-e053-2a95a90abd63 | 2021-04-12 | Adverse reactions | SODIUM CHLORIDE |
| CVS Health Sterile Saline Mist Live Better | SODIUM CHLORIDE | CVS Pharmacy | ccc3ab8c-b22f-420d-869b-f2a65b8c7180 | 2021-03-13 | Warnings | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | aeaed9cb-b629-4019-88d2-a916179427de | 2021-02-19 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Asclemed USA, Inc. | a411c118-ef0e-4c42-9924-4a06ec690e94 | 2021-01-14 | Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ac0fd44a-3f39-8d7e-e053-2995a90afeec | 2020-08-04 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| WinCo Foods Saline Nasal Relief | SODIUM CHLORIDE | WinCo Foods, LLC | 1280fee4-e763-49ba-8722-8cdb8157f1a4 | 2018-08-02 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 05dee566-7b82-4216-8a6b-765d2b4d9dc7 | 2018-07-17 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 181705c7-40e4-4d7d-b9ea-ada99380e7a9 | 2018-05-23 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 7c72520e-de3c-493d-8aea-11933376d968 | 2018-04-02 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 886f889b-f3cf-4197-b307-6cfa88c89436 | 2017-05-04 | SODIUM CHLORIDE | |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2a96096d-43cc-49b7-af53-b53c17f41001 | 2014-07-25 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | b3b4b176-41f0-4ca8-90d4-3fba5707564a | 2014-02-21 | SODIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 1254 | SUPPL | 2003-12-11 |