Application 202981

Type: ANDA
Sponsor: HOSPIRA INC

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202981-001	SODIUM BICARBONATE	SODIUM BICARBONATE	2.5MEQ/5ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202981-001	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 2 · 41 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	A202981-001	SODIUM BICARBONATE	2.5MEQ/5ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202981-001	SODIUM BICARBONATE	2.5MEQ/5ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP		2016-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION			2016-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION			2016-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202981-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2016-03-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202981-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202981-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202981-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202981-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202981-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202981-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202981-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202981-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202981-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202981-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202981-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202981-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202981-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202981-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202981-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202981-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202981-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202981-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202981-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202981-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202981-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202981-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202981-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202981-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202981-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202981-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202981-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202981-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202981-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202981-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202981-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202981-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202981-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202981-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202981-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202981-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202981-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202981-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202981-001	AP	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	9ee46a5b-d00e-4254-e053-2995a90aeb3a	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202981 application number: ANDA202981 ndc (product): 51662-1497
Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ea9f4498-0d43-4043-8dd1-f22537841c21	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202981 application number: ANDA202981 ndc (product): 0409-5555
Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	0c24b592-4bc8-456f-acac-9c9525844a06	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202981 application number: ANDA202981 ndc (product): 0409-5555
SODIUM BICARBONATE	SODIUM BICARBONATE	Henry Schein, Inc.	da484a2f-154f-48b4-8467-7a86729204c3	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202981 application number: ANDA202981 ndc (product): 0404-9951

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
0404-9951	SODIUM BICARBONATE	sodium bicarbonate	Henry Schein, Inc.	ANDA	Current
0404-9951	SODIUM BICARBONATE	sodium bicarbonate	Henry Schein, Inc.	ANDA	Current
0409-5555	Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ANDA	Current
0409-5555	Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ANDA	Current
0409-5555	Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ANDA	Current
51662-1497	SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-096	SODIUM BICARBONATE	sodium bicarbonate	General Injectables & Vaccines, Inc.	ANDA	Current
52584-096	SODIUM BICARBONATE	sodium bicarbonate	General Injectables & Vaccines, Inc.	ANDA	Current
52584-096	SODIUM BICARBONATE	sodium bicarbonate	General Injectables & Vaccines, Inc.	ANDA	Current
52584-096	SODIUM BICARBONATE	sodium bicarbonate	General Injectables & Vaccines, Inc.	ANDA	Current