Application 077394

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM BICARBONATE	SODIUM BICARBONATE	INJECTABLE;INJECTION	0.9MEQ/ML	No	Yes
002	SODIUM BICARBONATE	SODIUM BICARBONATE	INJECTABLE;INJECTION	1MEQ/ML	No	Yes

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
A077394-001	SODIUM BICARBONATE	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09
A077394-002	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077394-001	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077394-002	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077394-001	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077394-002	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077394-001	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077394-002	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077394-001	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077394-002	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS			2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION			2005-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077394-001	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2005-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077394-002	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2005-11-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077394-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077394-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077394-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077394-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077394-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077394-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077394-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077394-002	AP	1	`ea99ee380514…`

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 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	b620938d-ab2d-0934-e053-2a95a90a8483	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	d1636b56-ad83-4439-e053-2a95a90a135e	2023-05-02	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	International Medication Systems, Limited	77698221-a01d-4568-a7bc-d3d4e982875d	2021-12-15	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	bfc9c321-665c-ca97-e053-2995a90a7954	2021-04-12	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Aphena Pharma Solutions - Tennessee, LLC	15605a6d-6c90-47d5-9d1f-f66a3f27d5fc	2017-12-13	Warnings	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	Richmond Pharmaceuticals, Inc.	e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce	2017-11-01	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Richmond Pharmaceuticals, Inc.	fa10d93d-b3ed-4675-a117-f573d9e72bca	2017-10-30	Warnings	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	e9698a4f-1a95-4f28-a945-e8009d1d6dd4	2017-09-27	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52584-637	Sodium Bicarbonate	Sodium Bicarbonate	General Injectables & Vaccines, Inc	ANDA	Current
52584-637	Sodium Bicarbonate	Sodium Bicarbonate	General Injectables & Vaccines, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39529	ORIG	2012-11-26
31234	ORIG	2005-11-18