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 |
|---|---|---|---|---|---|---|
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | d98bf9f7-30ec-4927-a577-cabad192cb18 | 2026-01-19 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride Hypertonicity | SODIUM CHLORIDE | CVS Pharmacy | 9245d842-7f78-42d8-83ba-8eb9ec8dbc0d | 2026-01-15 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride Hypertonicity | SODIUM CHLORIDE | CVS PHARMACY | d5cc6cd1-ddf8-4f5b-a021-204cdda0db94 | 2026-01-15 | Warnings | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | BECTON DICKINSON AND COMPANY | d39b7307-df67-4e68-acb0-2eda5dc61215 | 2026-01-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Normal Salt | SODIUM CHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | f3f09817-8a38-4aa1-956b-69d9cf695074 | 2025-12-25 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ProPharma Distribution | 3f79fb8b-d0e8-db2a-e063-6394a90ac136 | 2025-12-18 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Rhinomel Manuka | SODIUM CHLORIDE | Melcare Biomedical Pty Ltd | 35a7ce7d-4a26-e3f0-e063-6294a90ad66f | 2025-12-09 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | SOLA Pharmaceuticals, LLC | 4d0bfd28-460a-48ba-bd17-cf75e56d62f4 | 2025-12-09 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sterile Saline Mist Meijer | SODIUM CHLORIDE | Meijer, Inc. | 445c8f4f-0519-0764-e063-6294a90a8b39 | 2025-12-01 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Walgreen Company | d112a344-33cc-41d3-bae6-492631ebdba7 | 2025-11-19 | Warnings | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ce0c8c6f-734a-400f-9b60-a3b1e263f25f | 2025-11-18 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Hospira, Inc. | af6aebad-ef03-4d19-9a40-18e5a278b812 | 2025-11-11 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Henry Schein, Inc. | 2e81ffca-05c6-4fa0-8911-4b3cbfa71351 | 2025-11-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Rising Pharma Holdings, Inc. | 42870188-b1d7-4934-a6c0-310530497dac | 2025-11-07 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | d8b8d796-bfba-42af-a859-99d776871558 | 2025-11-07 | Adverse reactions | SODIUM CHLORIDE |
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | 31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4 | 2025-11-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 3cfdeee0-ff14-4341-8396-b11c2a037c60 | 2025-11-02 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 5f372b75-d7a4-471e-8ac6-290040fc84b0 | 2025-11-02 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | 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 |