Home NDC 0409-5555 Sodium Bicarbonate
Product NDC 0409-5555
11-digit product format 004095555
Labeler code 0409
Product ID 0409-5555_bcb3a2dc-1a3f-4ac7-8ea2-426f0771c246
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM BICARBONATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA202981
Marketing category ANDA
Marketing start 2019-10-21
Substance SODIUM BICARBONATE
Active strength 42 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 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 2027-12-31 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 0409-5555-02 Sodium Bicarbonate 25 in 1 TRAY INJECTION, SOLUTION 25 11 0409-5555-12 Sodium Bicarbonate 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 11 0409-5555-01 Sodium Bicarbonate 25 in 1 TRAY INJECTION, SOLUTION 25 10 0409-5555-11 Sodium Bicarbonate 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-5555 SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250330_ea9f4498-0d43-4043-8dd1-f22537841c21.zip 0409-5555 SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20241031_0c24b592-4bc8-456f-acac-9c9525844a06.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 ndc (product): 0409-5555 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 ndc (product): 0409-5555 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
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 0409-5555-01 00409555501 25 VIAL, SINGLE-USE in 1 TRAY (0409-5555-01) / 5 mL in 1 VIAL, SINGLE-USE (0409-5555-11) 2020-08-26 0000-00-00 No No Current 0409-5555-02 00409555502 25 VIAL, SINGLE-USE in 1 TRAY (0409-5555-02) / 5 mL in 1 VIAL, SINGLE-USE (0409-5555-12) 2019-10-21 0000-00-00 No No Current 0409-5555-11 00409555511 5 mL in 1 VIAL, SINGLE-USE 5 ml Historical 0409-5555-12 00409555512 5 mL in 1 VIAL, SINGLE-USE 5 ml Historical