Application 018502
- Type
- NDA
- Sponsor
- MILES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 900MG/100ML | No | No |
| 002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 450MG/50ML (9MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | ||
| N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 |
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 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | SOLUTION / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018502-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 450MG/50ML (9MG/ML) | SOLUTION / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018502-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… |
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 |
|---|---|---|---|---|---|---|
| Worafy Gentle Eye Wash | SODIUM CHLORIDE | Shenzhen Shandian Jingling Technology Co., Ltd. | 4da864dc-e10c-1db9-e063-6394a90a0984 | 2026-03-22 | Warnings | SODIUM CHLORIDE |
| SODIUM CHLORIDE HYPERTONICITY | SODIUM CHLORIDE | YYBA CORP | 439653b9-99b8-4799-8d67-4a2ada9c6783 | 2026-03-20 | Warnings | SODIUM CHLORIDE |
| Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent | SODIUM CHLORIDE | Altaire Pharmaceuticals Inc. | e13fd053-9420-490c-a43e-e14b0930cb4e | 2026-03-18 | Warnings | SODIUM CHLORIDE |
| RESP EASE | SODIUM CHLORIDE | Venture Healthcare Ltd | 31b812c9-fb0a-5ee0-e063-6294a90a03e1 | 2026-03-16 | Warnings | SODIUM CHLORIDE |
| RESP EASE | SODIUM CHLORIDE | Venture Healthcare Ltd | 31b88e7c-eca0-5540-e063-6294a90a1b18 | 2026-03-16 | Warnings | SODIUM CHLORIDE |
| RESP EASE | SODIUM CHLORIDE | Venture Healthcare Ltd | 31b8c3f4-e528-c69d-e063-6294a90a5a34 | 2026-03-16 | Warnings | SODIUM CHLORIDE |
| RESP EASE | SODIUM CHLORIDE | Laboratoire Unither | 31b7eb13-39c3-6f0e-e063-6394a90a4011 | 2026-03-16 | Warnings | SODIUM CHLORIDE |
| RESP EASE | SODIUM CHLORIDE | Laboratoire Unither | 31b8bb9c-d30f-152f-e063-6394a90a5208 | 2026-03-16 | Warnings | SODIUM CHLORIDE |
| RESP EASE | SODIUM CHLORIDE | Laboratoire Unither | 31b8dcbd-9e6b-1edc-e063-6394a90aac73 | 2026-03-16 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | 018a8807-1331-41c3-4889-c7ec502a9043 | 2026-03-09 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Oimmal Gentle Eye Wash | SODIUM CHLORIDE | Shenzhen Shandian Jingling Technology Co., Ltd. | 4bb4e59b-a43e-fa38-e063-6294a90aea71 | 2026-02-26 | Warnings | SODIUM CHLORIDE |
| sodium chloride | SODIUM CHLORIDE | Medefil, Inc. | d1468c0f-dd4f-4d38-a84c-c1d110303965 | 2026-02-26 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| 0.9 percentsaline | SODIUM CHLORIDE | Huizhou Jinsheng Medical Technology Co., Ltd | 487cb4fc-2e0b-020f-e063-6294a90a4526 | 2026-02-03 | Warnings | SODIUM CHLORIDE |
| 0.9saline | SODIUM CHLORIDE | Huizhou Jinsheng Medical Technology Co., Ltd | 49e76aca-ca2b-3b95-e063-6394a90a875e | 2026-02-03 | Warnings | SODIUM CHLORIDE |
| 0.9%saline | SODIUM CHLORIDE | Huizhou Jinsheng Medical Technology Co., Ltd | 49e7b329-e4e5-6991-e063-6294a90ac817 | 2026-02-03 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Nephron Pharmaceuticals Corporation | a4edf2d5-a9ff-30d4-e053-2995a90a5650 | 2026-01-26 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ProPharma Distribution | 48d73434-e65b-dc98-e063-6294a90affa2 | 2026-01-20 | Adverse reactions | SODIUM CHLORIDE |
| 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 |