Sodium Bicarbonate

Product NDC: 51754-8020
11-digit product format: 517548020
Labeler code: 51754
Product ID: 51754-8020_f8806ec3-a1c0-47a9-9660-2628dca4623e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM BICARBONATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Exela Pharma Sciences, LLC
Application: ANDA211091
Marketing category: ANDA
Marketing start: 2019-08-01
Substance: SODIUM BICARBONATE
Active strength: 84 mg/mL
Pharmacologic classes: Alkalinizing Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211091-001	SODIUM BICARBONATE	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20
A211091-002	SODIUM BICARBONATE	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20
A211091-003	SODIUM BICARBONATE	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20
A211091-004	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211091-001	AP
A211091-002	AP
A211091-003	AP
A211091-004	AP

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 4 · 134 observed states.

Captured, Edition, Application-product table
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	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211091-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211091-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211091-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211091-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211091-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-003	AP	1	`d06236e962d9…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium Bicarbonate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM BICARBONATE	84 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8MDF5V39QO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1868486	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f8806ec3-a1c0-47a9-9660-2628dca4623e	Available on FDA.report

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	f8806ec3-a1c0-47a9-9660-2628dca4623e	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091 ndc (product): 51754-8020
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	2f05947f-a489-4298-a871-90db75b2a6c5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Civica	a10fdfbc-94a0-49ab-b26c-de1df042bc89	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	A-S Medication Solutions	d89406d3-4356-4a8c-acc1-89efe1d27010	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	09cf38c2-0b44-eca1-e063-6294a90a72d8	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	e9698a4f-1a95-4f28-a945-e8009d1d6dd4	2017-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51754-8020-4	51754802004	25 VIAL in 1 CARTON (51754-8020-4) / 50 mL in 1 VIAL	25 vial	2026-08-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Bicarbonate Injection, USP	Exela Pharma Sciences, LLC	2026-08-25	HUMAN PRESCRIPTION DRUG LABEL	1