Application 211091

Type: ANDA
Sponsor: EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM BICARBONATE	SODIUM BICARBONATE	INJECTABLE;INJECTION	0.5MEQ/ML	No	No
002	SODIUM BICARBONATE	SODIUM BICARBONATE	INJECTABLE;INJECTION	0.9MEQ/ML	No	No
003	SODIUM BICARBONATE	SODIUM BICARBONATE	INJECTABLE;INJECTION	1MEQ/ML	No	No
004	SODIUM BICARBONATE	SODIUM BICARBONATE	SOLUTION;INTRAVENOUS	50MEQ/50ML (1MEQ/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 126 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211091-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211091-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211091-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211091-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211091-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211091-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211091-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211091-002	AP	1	`1e350fbaab3a…`

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 · 5 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	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 ndc (product): 72572-740
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 ndc (product): 51754-5001 ndc (product): 51754-5011 ndc (product): 51754-5002 ndc (product): 51754-5012

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-5001	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5001	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5001	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5002	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5002	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5011	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5011	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5012	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
51754-5012	Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	ANDA	Current
72572-740	Sodium Bicarbonate	SODIUM BICARBONATE	Civica	ANDA	Current