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BICARBONATE | INJECTABLE;INJECTION | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| SODIUM BICARBONATE | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | |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| SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 |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IN PLASTIC CONTAINER | 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 84e616aacf4f… | |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IN PLASTIC CONTAINER | 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1986-06-03 | 84e616aacf4f… | |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 |
|---|---|---|---|---|---|---|
| EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon | SODIUM BICARBONATE | Lotus Brands, Inc. | 6703b29d-cdc9-4c74-91c0-fb0c98dd043e | 2024-12-18 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Cardinal Health 107, LLC | f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f | 2024-11-07 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Rising Pharma Holdings, Inc. | f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e | 2024-11-01 | Boxed warning, Warnings | SODIUM BICARBONATE |
| Insect sting relief latex 01 | SODIUM BICARBONATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 1b9e2d4c-bc0c-6ed0-e063-6294a90a9103 | 2024-08-19 | Warnings | SODIUM BICARBONATE |
| Insect sting relief pad 01 | SODIUM BICARBONATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 1b0f0088-6482-6de7-e063-6294a90aeeb7 | 2024-06-17 | Warnings | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Sun Pharmaceutical Industries Limited | 5ae65432-04a1-4b6b-8536-2535064fc782 | 2024-03-06 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Steriscience Specialties Private Limited | eb2996b4-c04c-4678-b8a9-5cbbe509bb70 | 2024-03-04 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Bryant Ranch Prepack | 4493d7c5-f2c3-416e-a5c1-35398fc7f61d | 2024-02-29 | Boxed warning, Warnings | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | HF Acquisition Co LLC, DBA HealthFirst | a5eedf57-2783-b3d0-e053-2a95a90a9ff5 | 2024-02-22 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| SODIUM BICARBONATE | SODIUM BICARBONATE | HF Acquisition Co LLC, DBA HealthFirst | 76131655-3a87-feac-e053-2991aa0a82a1 | 2024-01-28 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Pharma Nobis, LLC | e42f674b-1a70-6a3c-e053-2995a90afa72 | 2023-12-22 | Warnings | SODIUM BICARBONATE |
| Medis Sodium Bicarbonate | SODIUM BICARBONATE | Humco Holding Group, Inc | 5da32469-58fc-14b1-e053-2a91aa0a74c4 | 2023-12-15 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | Rugby Laboratories | e73b5871-4a87-4473-ab00-5e5395be017d | 2023-12-06 | Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | A-S Medication Solutions | d89406d3-4356-4a8c-acc1-89efe1d27010 | 2023-11-14 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | 09cf38c2-0b44-eca1-e063-6294a90a72d8 | 2023-11-10 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | APNAR PHARMA LP | e206c240-55c2-2d00-e053-2a95a90a1779 | 2023-10-21 | Boxed warning, Warnings | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | OMNIVIUM PHARMACEUTICALS LLC. | aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc | 2023-08-10 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | A-S Medication Solutions | 619cb558-84e5-43ea-91e9-28c764f9f9c0 | 2023-06-21 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | b620938d-ab2d-0934-e053-2a95a90a8483 | 2023-05-23 | Warnings, Adverse reactions | SODIUM BICARBONATE |
| Sodium Bicarbonate | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | d1636b56-ad83-4439-e053-2a95a90a135e | 2023-05-02 | Warnings, Adverse reactions | SODIUM BICARBONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.