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 1 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	REMEDYREPACK INC.	96093b76-5d98-4d2b-b851-20207a8864db	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	f8806ec3-a1c0-47a9-9660-2628dca4623e	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
sodium bicarbonate	SODIUM BICARBONATE	Baxter Healthcare Corporation	b50c858a-00c8-4cb2-ad73-8797f19e656d	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: sodium bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Milla Pharmaceuticals Inc.	2d2035c2-e41b-4d57-a23c-fae16ad9a355	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate 5 gr	SODIUM BICARBONATE	TWIN MED LLC	e325d899-d9a6-5adb-e053-2995a90ac861	2026-08-04	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Amneal Pharmaceuticals Private Limited	ac91e834-e693-43a2-829b-56793453e8cc	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	9ee46a5b-d00e-4254-e053-2995a90aeb3a	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	d8516f38-6f92-32d1-e053-2995a90a96bf	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE, INJECTION	Civica, Inc.	3737e5e5-2296-4a3d-b8f1-dfea1eff1927	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate
Sodium Bicarbonate	SODIUM BICARBONATE	Cardinal Health 107, LLC	60c2a176-8854-4479-b853-d07fe9a1830c	2026-06-12	Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC.	5401e4ff-aa7a-3e97-e063-6294a90a24f0	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	2f05947f-a489-4298-a871-90db75b2a6c5	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa	2026-06-04	Warnings	Name fallback generic name: SODIUM BICARBONATE
Humco Sodium Bicarbonate	SODIUM BICARBONATE	Humco Holding Group, Inc.	aeaa34f6-216d-49f3-8393-c7bda96a3e32	2026-05-26	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Vitamex USA, Corp	5195cab5-bdda-2ddf-e063-6394a90ac9fe	2026-05-11	Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	TWIN MED LLC	0f867f56-4bc0-4a85-b9d2-a16282b7c82b	2026-05-01	Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Arm and Hammer Baking Soda	SODIUM BICARBONATE	Church & Dwight Co., Inc.	643fe204-4a7b-00e4-e053-2a91aa0aef06	2026-04-21	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	4f97d398-2118-0874-e063-6394a90a4ad1	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate 10 gr. (650 mg)	SODIUM BICARBONATE	Gendose Pharmaceuticals, LLC	0a0cc46d-372e-4175-932a-065e82d8d353	2026-04-13	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Hospira, Inc.	ea9f4498-0d43-4043-8dd1-f22537841c21	2026-04-06	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