SODIUM BICARBONATE

Product NDC: 71872-7371
Requested package NDC: 71872-7371-1
11-digit product format: 718727371
Labeler code: 71872
Product ID: 71872-7371_4f97cf3b-9e25-cd9c-e063-6294a90a2128
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM BICARBONATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: ANDA217594
Marketing category: ANDA
Marketing start: 2024-03-15
Substance: SODIUM BICARBONATE
Active strength: 84 mg/mL
Pharmacologic classes: Alkalinizing Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A217594-001	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP		2023-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217594-001	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	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION		2023-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION		2023-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217594-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2023-06-28	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217594-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-28	`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	A217594-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217594-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217594-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217594-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217594-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217594-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217594-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217594-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217594-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217594-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217594-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217594-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217594-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217594-001	AP	1	`8072bd15b7f6…`
2023-12-20 04:57 UTC	2023-12	A217594-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217594-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217594-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217594-001	AP	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217594-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: SODIUM BICARBONATE
Listing expiration: 2027-12-31

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
4f97d398-2118-0874-e063-6394a90a4ad1	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
71872-7371-1	SODIUM BICARBONATE	50 mL in 1 VIAL	INJECTION, SOLUTION	50		1
71872-7371-1	SODIUM BICARBONATE	1 in 1 BAG	INJECTION, SOLUTION	1		1

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 · 4 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	4f97d398-2118-0874-e063-6394a90a4ad1	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594 ndc (package): 71872-7371-1 ndc (product): 71872-7371 ndc11 (package): 71872737101
SODIUM BICARBONATE	SODIUM BICARBONATE	ProPharma Distribution	3867f743-c2cf-a646-e063-6394a90a82e1	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594
SODIUM BICARBONATE	SODIUM BICARBONATE	Sun Pharmaceutical Industries Limited	5ae65432-04a1-4b6b-8536-2535064fc782	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594
Sodium Bicarbonate	SODIUM BICARBONATE	Steriscience Specialties Private Limited	eb2996b4-c04c-4678-b8a9-5cbbe509bb70	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217594 application number: ANDA217594

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	4f97d398-2118-0874-e063-6394a90a4ad1	1
1868486	50 ML sodium bicarbonate 84 MG/ML Injection	SCD	4f97d398-2118-0874-e063-6394a90a4ad1	1
1868486	50 ML NaHCO3 84 MG/ML Injection	SY	4f97d398-2118-0874-e063-6394a90a4ad1	1
1868486	sodium bicarbonate 8.4 % (50 MEQ) per 50 ML Injection	SY	4f97d398-2118-0874-e063-6394a90a4ad1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71872-7371-1	71872737101	1 VIAL in 1 BAG (71872-7371-1) / 50 mL in 1 VIAL	1 vial	2026-04-15	No	No	Current