Application 019443
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | SODIUM BICARBONATE | INJECTABLE;INJECTION | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | SODIUM BICARBONATE | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | |
| N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 |
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 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML | INJECTABLE / INJECTION | RLD | 1986-06-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML | INJECTABLE / INJECTION | RLD | 1986-06-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML | INJECTABLE / INJECTION | RLD | 1986-06-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML | INJECTABLE / INJECTION | RLD | 1986-06-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019443-001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019443-002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1986-06-03 | 74a2ff9319b5… |
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 Bicarbonate | SODIUM BICARBONATE | International Medication Systems, Limited | 77698221-a01d-4568-a7bc-d3d4e982875d | 2021-12-15 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | bfc9c321-665c-ca97-e053-2995a90a7954 | 2021-04-12 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Aphena Pharma Solutions - Tennessee, LLC | 15605a6d-6c90-47d5-9d1f-f66a3f27d5fc | 2017-12-13 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | Richmond Pharmaceuticals, Inc. | e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce | 2017-11-01 | Warnings | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Richmond Pharmaceuticals, Inc. | fa10d93d-b3ed-4675-a117-f573d9e72bca | 2017-10-30 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | e9698a4f-1a95-4f28-a945-e8009d1d6dd4 | 2017-09-27 | Warnings, Adverse reactions | SODIUM BICARBONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.