Sodium Bicarbonate

Product NDC: 72162-2314
11-digit product format: 721622314
Labeler code: 72162
Product ID: 72162-2314_f5039a39-178c-4a1c-9dcc-2d93e57378d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM BICARBONATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Bryant Ranch Prepack
Application: ANDA216364
Marketing category: ANDA
Marketing start: 2023-06-16
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 42.

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
2026-08-18 06:07:40	2026-07	A216364-001	SODIUM BICARBONATE	50MEQ/50ML (1MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`caaa826d4ba7…`
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
2026-08-18 06:07:40	2026-07	A216364-001	AP	1	`caaa826d4ba7…`
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…`

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
ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72162-2314-2	Sodium Bicarbonate	20 in 1 CARTON	INJECTION, SOLUTION	20	101
72162-2314-4	Sodium Bicarbonate	25 in 1 CARTON	INJECTION, SOLUTION	25	101
72162-2314-7	Sodium Bicarbonate	50 mL in 1 VIAL	INJECTION, SOLUTION	50	101
72162-2314-8	Sodium Bicarbonate	50 mL in 1 VIAL	INJECTION, SOLUTION	50	101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2314-2	ML - Milliliter	72162-2314	fdc924e4-41a9-4e80-a913-40f86048574d	1	2024-07-12
72162-2314-4	ML - Milliliter	72162-2314	1647e95f-1532-4ebd-acdf-ca9ca6386c2e	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2314	SODIUM BICARBONATE INJECTION, SOLUTION [BRYANT RANCH PREPACK]	100	Current NDC, 4 package rows	20240524_ccf8e08c-2efb-4a92-a4c2-042dba2eacfa.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 ndc (product): 72162-2314
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	ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	101
1868486	50 ML sodium bicarbonate 84 MG/ML Injection	SCD	ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	101
1868486	50 ML NaHCO3 84 MG/ML Injection	SY	ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	101
1868486	sodium bicarbonate 8.4 % (50 MEQ) per 50 ML Injection	SY	ccf8e08c-2efb-4a92-a4c2-042dba2eacfa	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2314-2	72162231402	20 VIAL in 1 CARTON (72162-2314-2) / 50 mL in 1 VIAL (72162-2314-7)	20 vial	2024-05-22	No	No	Current
72162-2314-4	72162231404	25 VIAL in 1 CARTON (72162-2314-4) / 50 mL in 1 VIAL (72162-2314-8)	25 vial	2024-05-22	No	No	Current
72162-2314-7	72162231407	50 mL in 1 VIAL	50 ml				Historical
72162-2314-8	72162231408	50 mL in 1 VIAL	50 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Bicarbonate Injection, USP	Bryant Ranch Prepack	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL	101