Home NDC 51754-5011 Sodium Bicarbonate
Product NDC 51754-5011
11-digit product format 517545011
Labeler code 51754
Product ID 51754-5011_4da0ba66-756d-4b4d-8018-81ca16578ef1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM BICARBONATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Exela Pharma Sciences, LLC
Application ANDA211091
Marketing category ANDA
Marketing start 2020-09-01
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 1 .
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.
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 · 126 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 2026-02-19 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211091-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211091-002 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211091-003 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211091-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211091-002 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211091-003 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211091-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211091-002 SODIUM BICARBONATE 0.9MEQ/ML INJECTABLE / INJECTION AP RS 2019-06-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 124 observed states.
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 807284 Internal RxNorm lookup 1868486 Internal RxNorm lookup 1923484 Internal RxNorm lookup 2198792 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51754-5011-4 Sodium Bicarbonate 25 in 1 CARTON INJECTION, SOLUTION 25 3 51754-5011-4 Sodium Bicarbonate 10 mL in 1 VIAL INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-5011 SODIUM BICARBONATE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20220826_e9698a4f-1a95-4f28-a945-e8009d1d6dd4.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 · 5 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 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 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 ndc (product): 51754-5011
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51754-5011-4 51754501104 25 VIAL in 1 CARTON (51754-5011-4) / 10 mL in 1 VIAL 25 vial 2020-09-01 0000-00-00 No No Current