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BICARBONATE | INJECTABLE;INJECTION | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| SODIUM BICARBONATE | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | |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| SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 |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IN PLASTIC CONTAINER | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 84e616aacf4f… | |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IN PLASTIC CONTAINER | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 84e616aacf4f… | |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 | REMEDYREPACK INC. | 96093b76-5d98-4d2b-b851-20207a8864db | 2026-08-28 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | f8806ec3-a1c0-47a9-9660-2628dca4623e | 2026-08-25 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| sodium bicarbonate | SODIUM BICARBONATE | Baxter Healthcare Corporation | b50c858a-00c8-4cb2-ad73-8797f19e656d | 2026-08-14 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Milla Pharmaceuticals Inc. | 2d2035c2-e41b-4d57-a23c-fae16ad9a355 | 2026-08-07 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate 5 gr | SODIUM BICARBONATE | TWIN MED LLC | e325d899-d9a6-5adb-e053-2995a90ac861 | 2026-08-04 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Amneal Pharmaceuticals Private Limited | ac91e834-e693-43a2-829b-56793453e8cc | 2026-07-09 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | HF Acquisition Co LLC, DBA HealthFirst | 9ee46a5b-d00e-4254-e053-2995a90aeb3a | 2026-06-29 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | HF Acquisition Co LLC, DBA HealthFirst | d8516f38-6f92-32d1-e053-2995a90a96bf | 2026-06-19 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Cardinal Health 107, LLC | 60c2a176-8854-4479-b853-d07fe9a1830c | 2026-06-12 | Warnings | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC. | 5401e4ff-aa7a-3e97-e063-6294a90a24f0 | 2026-06-11 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Exela Pharma Sciences, LLC | 2f05947f-a489-4298-a871-90db75b2a6c5 | 2026-06-09 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | NCS HealthCare of KY, LLC dba Vangard Labs | fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa | 2026-06-04 | Warnings | SODIUM BICARBONATE |
| Humco Sodium Bicarbonate | SODIUM BICARBONATE | Humco Holding Group, Inc. | aeaa34f6-216d-49f3-8393-c7bda96a3e32 | 2026-05-26 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Vitamex USA, Corp | 5195cab5-bdda-2ddf-e063-6394a90ac9fe | 2026-05-11 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | TWIN MED LLC | 0f867f56-4bc0-4a85-b9d2-a16282b7c82b | 2026-05-01 | Warnings | SODIUM BICARBONATE |
| Arm and Hammer Baking Soda | SODIUM BICARBONATE | Church & Dwight Co., Inc. | 643fe204-4a7b-00e4-e053-2a91aa0aef06 | 2026-04-21 | Warnings | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | 4f97d398-2118-0874-e063-6394a90a4ad1 | 2026-04-16 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate 10 gr. (650 mg) | SODIUM BICARBONATE | Gendose Pharmaceuticals, LLC | 0a0cc46d-372e-4175-932a-065e82d8d353 | 2026-04-13 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Hospira, Inc. | ea9f4498-0d43-4043-8dd1-f22537841c21 | 2026-04-06 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Hospira, Inc. | 8664c7ce-707b-4c6c-9ce4-7160b5f877f8 | 2026-04-06 | Warnings, Adverse reactions | SODIUM BICARBONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.