SODIUM BICARBONATE

Product NDC: 71872-7376
11-digit product format: 718727376
Labeler code: 71872
Product ID: 71872-7376_5401e4ff-aa7b-3e97-e063-6294a90a24f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM BICARBONATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC.
Application: ANDA219701
Marketing category: ANDA
Marketing start: 2025-08-07
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 43.

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
A219701-001	SODIUM BICARBONATE	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP		2025-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219701-001	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
2026-09-14 22:38:34	2026-08	A219701-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219701-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219701-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219701-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219701-001	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE / INJECTION	AP	2025-06-26	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219701-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-06-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219701-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219701-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219701-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219701-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219701-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219701-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
5401e4ff-aa7a-3e97-e063-6294a90a24f0	Available on FDA.report

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 · 3 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.	5401e4ff-aa7a-3e97-e063-6294a90a24f0	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219701 application number: ANDA219701 ndc (product): 71872-7376
SODIUM BICARBONATE	SODIUM BICARBONATE	Glenmark Pharmaceuticals Inc., USA	f38d0dfc-9bcc-4224-a202-885c9ad0beae	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219701 application number: ANDA219701
SODIUM BICARBONATE	SODIUM BICARBONATE	Anthea Pharma Private Limited	0df8cf62-4b49-4ec4-aae4-c4a3e6d76549	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219701 application number: ANDA219701

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71872-7376-1	71872737601	1 VIAL in 1 BAG (71872-7376-1) / 50 mL in 1 VIAL	1 vial	2026-06-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM BICARBONATE	Medical Purchasing Solutions, LLC. \| Medical Purchasing Solutions, LLC	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	1