Home NDC 0404-9951 SODIUM BICARBONATE
Product NDC 0404-9951
11-digit product format 004049951
Labeler code 0404
Product ID 0404-9951_1cc6a0c6-0475-4c98-92ab-a6184974cfd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium bicarbonate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA202981
Marketing category ANDA
Marketing start 2022-01-12
Substance SODIUM BICARBONATE
Active strength 42 mg/mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202981-001 SODIUM BICARBONATE SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2016-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202981-001 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.
Product history page 1 of 2 · 41 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 A202981-001 SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2016-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202981-001 SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2016-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP 2016-03-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION 2016-03-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION 2016-03-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202981-001 SODIUM BICARBONATE 0.5MEQ/ML INJECTABLE / INJECTION AP RS 2016-03-04 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 42 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 1868469 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 0404-9951-05 SODIUM BICARBONATE 1 in 1 BAG INJECTION, SOLUTION 1 5 0404-9951-05 SODIUM BICARBONATE 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9951 SODIUM BICARBONATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240817_da484a2f-154f-48b4-8467-7a86729204c3.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SODIUM BICARBONATE SODIUM BICARBONATE HF Acquisition Co LLC, DBA HealthFirst 9ee46a5b-d00e-4254-e053-2995a90aeb3a 2026-06-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202981 application number: ANDA202981 Sodium Bicarbonate SODIUM BICARBONATE Hospira, Inc. ea9f4498-0d43-4043-8dd1-f22537841c21 2026-04-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202981 application number: ANDA202981 Sodium Bicarbonate SODIUM BICARBONATE Hospira, Inc. 0c24b592-4bc8-456f-acac-9c9525844a06 2026-03-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202981 application number: ANDA202981 SODIUM BICARBONATE SODIUM BICARBONATE Henry Schein, Inc. da484a2f-154f-48b4-8467-7a86729204c3 2025-11-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202981 application number: ANDA202981 ndc (product): 0404-9951
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9951-05 00404995105 1 VIAL, SINGLE-USE in 1 BAG (0404-9951-05) / 5 mL in 1 VIAL, SINGLE-USE 2022-01-12 0000-00-00 No No Current