Application 019443

Type: NDA
Sponsor: ABBOTT

Application Products#

Product, Drug, Ingredient table
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SODIUM BICARBONATE	INJECTABLE;INJECTION	0.9MEQ/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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SODIUM BICARBONATE	INJECTABLE;INJECTION	1MEQ/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	1986-06-03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CONTAINER	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	1986-06-03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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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SODIUM BICARBONATE IN PLASTIC CONTAINER	0.9MEQ/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-06-03	`74a2ff9319b5…`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SODIUM BICARBONATE IN PLASTIC CONTAINER	1MEQ/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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.

Matched openFDA labels page 1 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	f8806ec3-a1c0-47a9-9660-2628dca4623e	2026-08-25	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
sodium bicarbonate	SODIUM BICARBONATE	Baxter Healthcare Corporation	b50c858a-00c8-4cb2-ad73-8797f19e656d	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Milla Pharmaceuticals Inc.	2d2035c2-e41b-4d57-a23c-fae16ad9a355	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate 5 gr	SODIUM BICARBONATE	TWIN MED LLC	e325d899-d9a6-5adb-e053-2995a90ac861	2026-08-04	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Amneal Pharmaceuticals Private Limited	ac91e834-e693-43a2-829b-56793453e8cc	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	9ee46a5b-d00e-4254-e053-2995a90aeb3a	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	d8516f38-6f92-32d1-e053-2995a90a96bf	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Cardinal Health 107, LLC	60c2a176-8854-4479-b853-d07fe9a1830c	2026-06-12	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC.	5401e4ff-aa7a-3e97-e063-6294a90a24f0	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	2f05947f-a489-4298-a871-90db75b2a6c5	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa	2026-06-04	Warnings	Name fallback generic name: SODIUM BICARBONATE
Humco Sodium Bicarbonate	SODIUM BICARBONATE	Humco Holding Group, Inc.	aeaa34f6-216d-49f3-8393-c7bda96a3e32	2026-05-26	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Vitamex USA, Corp	5195cab5-bdda-2ddf-e063-6394a90ac9fe	2026-05-11	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	TWIN MED LLC	0f867f56-4bc0-4a85-b9d2-a16282b7c82b	2026-05-01	Warnings	Name fallback generic name: SODIUM BICARBONATE
Arm and Hammer Baking Soda	SODIUM BICARBONATE	Church & Dwight Co., Inc.	643fe204-4a7b-00e4-e053-2a91aa0aef06	2026-04-21	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	4f97d398-2118-0874-e063-6394a90a4ad1	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate 10 gr. (650 mg)	SODIUM BICARBONATE	Gendose Pharmaceuticals, LLC	0a0cc46d-372e-4175-932a-065e82d8d353	2026-04-13	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ea9f4498-0d43-4043-8dd1-f22537841c21	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	8664c7ce-707b-4c6c-9ce4-7160b5f877f8	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.