Sodium Bicarbonate

Product NDC: 72572-740
11-digit product format: 725720740
Labeler code: 72572
Product ID: 72572-740_8fcbd37e-e4d5-4137-9abf-c398fbb5cbf0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM BICARBONATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Civica
Application: ANDA211091
Marketing category: ANDA
Marketing start: 2019-08-01
Substance: SODIUM BICARBONATE
Active strength: 84 mg/mL
Pharmacologic classes: Alkalinizing Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211091-001	SODIUM BICARBONATE	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20
A211091-002	SODIUM BICARBONATE	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20
A211091-003	SODIUM BICARBONATE	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20
A211091-004	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211091-001	AP
A211091-002	AP
A211091-003	AP
A211091-004	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 4 · 134 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	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-001	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-002	SODIUM BICARBONATE	44.6MEQ/50ML (0.9MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-003	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-004	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211091-001	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-002	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-003	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	RS	2019-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211091-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211091-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211091-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211091-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211091-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211091-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211091-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211091-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211091-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211091-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211091-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211091-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211091-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211091-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211091-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211091-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211091-003	AP	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium Bicarbonate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM BICARBONATE	84 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8MDF5V39QO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1868486	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a10fdfbc-94a0-49ab-b26c-de1df042bc89	Available on FDA.report

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
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
72572-740-25	Sodium Bicarbonate	50 mL in 1 VIAL	INJECTION, SOLUTION	50		3
72572-740-25	Sodium Bicarbonate	25 in 1 CARTON	INJECTION, SOLUTION	25		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72572-740-20	ML - Milliliter	72572-740	de9e6ea1-44c0-4ede-ba0f-913e3b774e5e	1	2020-03-10
72572-740-25	ML - Milliliter	72572-740	14ae7843-8fe6-4e55-b46b-a294931094da	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72572-740	SODIUM BICARBONATE INJECTION, SOLUTION [CIVICA]	2	Current NDC, Legacy NDC, 2 package rows	20240110_a10fdfbc-94a0-49ab-b26c-de1df042bc89.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	f8806ec3-a1c0-47a9-9660-2628dca4623e	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	2f05947f-a489-4298-a871-90db75b2a6c5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Civica	a10fdfbc-94a0-49ab-b26c-de1df042bc89	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091 ndc (product): 72572-740
Sodium Bicarbonate	SODIUM BICARBONATE	A-S Medication Solutions	d89406d3-4356-4a8c-acc1-89efe1d27010	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	09cf38c2-0b44-eca1-e063-6294a90a72d8	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	e9698a4f-1a95-4f28-a945-e8009d1d6dd4	2017-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211091 application number: ANDA211091

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	a10fdfbc-94a0-49ab-b26c-de1df042bc89	3
1868486	50 ML sodium bicarbonate 84 MG/ML Injection	SCD	a10fdfbc-94a0-49ab-b26c-de1df042bc89	3
1868486	50 ML NaHCO3 84 MG/ML Injection	SY	a10fdfbc-94a0-49ab-b26c-de1df042bc89	3
1868486	sodium bicarbonate 8.4 % (50 MEQ) per 50 ML Injection	SY	a10fdfbc-94a0-49ab-b26c-de1df042bc89	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72572-740-20	72572074020	20 VIAL in 1 CARTON (72572-740-20) > 50 mL in 1 VIAL	20 vial	2020-03-01	0000-00-00	No	No	Current
72572-740-25	72572074025	25 VIAL in 1 CARTON (72572-740-25) / 50 mL in 1 VIAL	25 vial	2024-02-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Bicarbonate Injection, USP	Civica \| Exela Pharma Sciences, LLC	2025-11-24	HUMAN PRESCRIPTION DRUG LABEL	3