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SODIUM BICARBONATE	INJECTABLE;INJECTION	0.9MEQ/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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SODIUM BICARBONATE	INJECTABLE;INJECTION	1MEQ/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

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SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	1986-06-03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CONTAINER	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	1986-06-03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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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IN PLASTIC CONTAINER	44.6MEQ/50ML (0.9MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1986-06-03	`84e616aacf4f…`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IN PLASTIC CONTAINER	50MEQ/50ML (1MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1986-06-03	`84e616aacf4f…`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.

Matched openFDA labels page 3 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
After Bite X Tech	SODIUM BICARBONATE	Adventure Ready Brands	e9e49ab4-3e1f-9fd4-e053-2a95a90a775a	2025-11-17	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Henry Schein, Inc.	da484a2f-154f-48b4-8467-7a86729204c3	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ea20a5eb-641e-48cd-bcfa-74c04c45dfda	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Fresenius Kabi USA, LLC	0ab55004-bb63-436d-ad77-cd3796905370	2025-09-23	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate 10 GR (650 MG)	SODIUM BICARBONATE	Advanced Rx LLC	634e8d52-6d04-42f9-98f6-2634473b5dfd	2025-09-01	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	ProPharma Distribution	3d71b046-3e0b-054a-e063-6294a90a563a	2025-08-28	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Bryant Ranch Prepack	ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	2025-08-13	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Henry Schein, Inc.	ea9ad1a6-84f2-44d8-bf93-fb8f3d3fce9c	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
Anti-Empacho	SODIUM BICARBONATE	Menper Distributors, Inc.	43807221-58f0-434d-be2d-fa0f54b95db8	2025-07-22	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	Menper Distributors Inc.	6efb4da0-03ae-4df6-acd7-e8023d20d4b3	2025-07-22	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Westminster Pharmaceuticals, LLC	9dcfc778-5fd6-4c68-8d37-a5385e374617	2025-07-08	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Anthea Pharma Private Limited	0df8cf62-4b49-4ec4-aae4-c4a3e6d76549	2025-06-26	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
AHHH Bite Relief	SODIUM BICARBONATE	78271	25a1e070-9228-4ec9-e063-6294a90ad78d	2025-05-27	Warnings	Name fallback generic name: SODIUM BICARBONATE
Bestmade Natural Products Sodium Bicarbonate (Nat Bicarb)	SODIUM BICARBONATE	Bestmade Natural Products	2fad1d83-3c64-f1b3-e063-6294a90aa3e5	2025-05-26	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate 10 gr (650 mg)	SODIUM BICARBONATE	CitraGen Pharmaceuticals Inc.	650fa284-5829-588f-e053-2991aa0a9a0e	2025-01-30	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate 5 gr (325 mg)	SODIUM BICARBONATE	CitraGen Pharmaceuticals Inc.	68aadbd9-f1c6-8a23-e053-2991aa0afd96	2025-01-30	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	World Perfumes Inc	a83544e4-ec09-1e95-e053-2995a90ab7b9	2025-01-15	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate 10 gr	SODIUM BICARBONATE	Reliable 1 Laboratories LLC	321a772c-c44c-3d4e-e054-00144ff8d46c	2025-01-15	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	9545d58c-1c49-79b3-e053-2995a90a9d40	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: SODIUM BICARBONATE
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	SODIUM BICARBONATE	Lotus Brands, Inc.	4a95c8c1-db7c-4791-ac58-3eac216a0126	2024-12-18	Warnings	Name fallback generic name: SODIUM BICARBONATE

Reported adverse events (FAERS/openFDA)#

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