Application 203449

Type: ANDA
Sponsor: INTL MEDICATION SYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM BICARBONATE	SODIUM BICARBONATE	INJECTABLE;INJECTION	1MEQ/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
A203449-001	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP		2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203449-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203449-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203449-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203449-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2017-09-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203449-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203449-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203449-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203449-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203449-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203449-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203449-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203449-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203449-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203449-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203449-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203449-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203449-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203449-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203449-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203449-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203449-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203449-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203449-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203449-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203449-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203449-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203449-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203449-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203449-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203449-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203449-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203449-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203449-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203449-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203449-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203449-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203449-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203449-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203449-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203449-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203449-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203449-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203449-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203449-001	AP	1	`cb3db0bc1861…`

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	REMEDYREPACK INC.	96093b76-5d98-4d2b-b851-20207a8864db	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203449 application number: ANDA203449
Sodium Bicarbonate	SODIUM BICARBONATE	ProPharma Distribution	3d71b046-3e0b-054a-e063-6294a90a563a	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203449 application number: ANDA203449
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	a5eedf57-2783-b3d0-e053-2a95a90a9ff5	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203449 application number: ANDA203449 ndc (product): 51662-1383
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	b620938d-ab2d-0934-e053-2a95a90a8483	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203449 application number: ANDA203449 ndc (product): 71872-7097
Sodium Bicarbonate	SODIUM BICARBONATE	International Medication Systems, Limited	77698221-a01d-4568-a7bc-d3d4e982875d	2021-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203449 application number: ANDA203449 ndc (product): 76329-3352

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1383	SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1383	SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1383	SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
71872-7097	Sodium Bicarbonate	Sodium Bicarbonate	Medical Purchasing Solutions, LLC	ANDA	Current
76329-3352	Sodium Bicarbonate	Sodium Bicarbonate	International Medication Systems, Limited	ANDA	Current
76329-3352	Sodium Bicarbonate	Sodium Bicarbonate	International Medication Systems, Limited	ANDA	Current