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 4 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	SODIUM BICARBONATE	Lotus Brands, Inc.	4a95c8c1-db7c-4791-ac58-3eac216a0126	2024-12-18	Warnings	Name fallback generic name: SODIUM BICARBONATE
EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon	SODIUM BICARBONATE	Lotus Brands, Inc.	6703b29d-cdc9-4c74-91c0-fb0c98dd043e	2024-12-18	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Cardinal Health 107, LLC	f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f	2024-11-07	Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Rising Pharma Holdings, Inc.	f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e	2024-11-01	Boxed warning, Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE INJECTION,	Long Grove Pharmaceuticals, LLC	a26d709b-b294-4b02-9a88-7e840f099a33	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE
Insect sting relief latex 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b9e2d4c-bc0c-6ed0-e063-6294a90a9103	2024-08-19	Warnings	Name fallback generic name: SODIUM BICARBONATE
Insect sting relief pad 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b0f0088-6482-6de7-e063-6294a90aeeb7	2024-06-17	Warnings	Name fallback generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	Sun Pharmaceutical Industries Limited	5ae65432-04a1-4b6b-8536-2535064fc782	2024-03-06	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Steriscience Specialties Private Limited	eb2996b4-c04c-4678-b8a9-5cbbe509bb70	2024-03-04	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Bryant Ranch Prepack	4493d7c5-f2c3-416e-a5c1-35398fc7f61d	2024-02-29	Boxed warning, Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	a5eedf57-2783-b3d0-e053-2a95a90a9ff5	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
SODIUM BICARBONATE	SODIUM BICARBONATE	HF Acquisition Co LLC, DBA HealthFirst	76131655-3a87-feac-e053-2991aa0a82a1	2024-01-28	Warnings, Adverse reactions	Name fallback brand name: SODIUM BICARBONATE generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Pharma Nobis, LLC	e42f674b-1a70-6a3c-e053-2995a90afa72	2023-12-22	Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Medis Sodium Bicarbonate	SODIUM BICARBONATE	Humco Holding Group, Inc	5da32469-58fc-14b1-e053-2a91aa0a74c4	2023-12-15	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	Rugby Laboratories	e73b5871-4a87-4473-ab00-5e5395be017d	2023-12-06	Warnings	Name fallback generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	A-S Medication Solutions	d89406d3-4356-4a8c-acc1-89efe1d27010	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	09cf38c2-0b44-eca1-e063-6294a90a72d8	2023-11-10	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	APNAR PHARMA LP	e206c240-55c2-2d00-e053-2a95a90a1779	2023-10-21	Boxed warning, Warnings	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	OMNIVIUM PHARMACEUTICALS LLC.	aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc	2023-08-10	Warnings, Adverse reactions	Name fallback brand name: Sodium Bicarbonate generic name: SODIUM BICARBONATE
Sodium Bicarbonate	SODIUM BICARBONATE	A-S Medication Solutions	619cb558-84e5-43ea-91e9-28c764f9f9c0	2023-06-21	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