Sodium Bicarbonate

Product NDC: 72603-209
Requested package NDC: 72603-209-25
11-digit product format: 726030209
Labeler code: 72603
Product ID: 72603-209_f2190c6c-50b8-4283-b715-1eabb7e4ff0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM BICARBONATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: NORTHSTAR RX LLC
Application: ANDA216364
Marketing category: ANDA
Marketing start: 2024-02-19
Marketing end: 2026-06-30
Substance: SODIUM BICARBONATE
Active strength: 84 mg/mL
Pharmacologic classes: Alkalinizing Activity [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72603-209	72603-209-25	D	Discontinued by firm		2026-08-11

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
A216364-001	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP		2023-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216364-001	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.

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	A216364-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216364-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216364-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-15	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216364-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`a50c72e98297…`

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	A216364-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216364-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216364-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216364-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216364-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216364-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216364-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216364-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216364-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216364-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216364-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216364-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216364-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216364-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216364-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216364-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216364-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216364-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216364-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216364-001	AP	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216364-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72603-209-01	Sodium Bicarbonate	50 mL in 1 VIAL	INJECTION, SOLUTION	50		2
72603-209-25	Sodium Bicarbonate	25 in 1 CARTON	INJECTION, SOLUTION	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-209-01	ML - Milliliter	72603-209	fa611d3f-9ca2-47e3-bebe-97464606ab7d	1	2024-05-16
72603-209-25	ML - Milliliter	72603-209	4effc12b-171c-4cfc-9fc2-36ca17042e33	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-209	SODIUM BICARBONATE INJECTION, SOLUTION [NORTHSTAR RX LLC]	1	Current NDC, 2 package rows	20240219_068db1fe-0346-48f1-8d2f-8488d7331106.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Bicarbonate	SODIUM BICARBONATE	Bryant Ranch Prepack	ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216364 application number: ANDA216364
Sodium Bicarbonate	SODIUM BICARBONATE	OMNIVIUM PHARMACEUTICALS LLC.	aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216364 application number: ANDA216364

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1868486	sodium bicarbonate 8.4 % (50 MEQ) in 50 ML Injection	PSN	068db1fe-0346-48f1-8d2f-8488d7331106	2
1868486	50 ML sodium bicarbonate 84 MG/ML Injection	SCD	068db1fe-0346-48f1-8d2f-8488d7331106	2
1868486	50 ML NaHCO3 84 MG/ML Injection	SY	068db1fe-0346-48f1-8d2f-8488d7331106	2
1868486	sodium bicarbonate 8.4 % (50 MEQ) per 50 ML Injection	SY	068db1fe-0346-48f1-8d2f-8488d7331106	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72603-209-25	72603020925	25 VIAL in 1 CARTON (72603-209-25) / 50 mL in 1 VIAL (72603-209-01)	25 vial	2024-02-19	2026-06-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Bicarbonate Injection, USP	NORTHSTAR RX LLC \| MAIVA PHARMA PVT. LTD.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	2