Home NDC 0409-6625-02 SODIUM BICARBONATE
Product NDC 0409-6625
Requested package NDC 0409-6625-02
11-digit product format 004096625
Labeler code 0409
Product ID 0409-6625_c39c0ef6-4140-4c6c-91c4-e43d67872b05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM BICARBONATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA202432
Marketing category ANDA
Marketing start 2021-03-01
Substance SODIUM BICARBONATE
Active strength 84 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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A202432-001 SODIUM BICARBONATE SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202432-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A202432-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202432-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202432-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202432-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202432-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-6625-14 SODIUM BICARBONATE 25 in 1 TRAY INJECTION, SOLUTION 25 7 0409-6625-22 SODIUM BICARBONATE 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 7 0409-6625-30 Sodium Bicarbonate 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 6 0409-6625-35 Sodium Bicarbonate 25 in 1 TRAY INJECTION, SOLUTION 25 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO SODIUM BICARBONATE INJECTION, SOLUTION [CARDINAL HEALTH] 3 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 SODIUM BICARBONATE INJECTION, SOLUTION [CARDINAL HEALTH] 3 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM BICARBONATE INJECTION, SOLUTION [CARDINAL HEALTH] 3 Sodium Bicarbonate ACTIVE INGREDIENT 8MDF5V39QO SODIUM BICARBONATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 2 Sodium Cation ACTIVE MOIETY LYR4M0NH37 SODIUM BICARBONATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 2 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO SODIUM BICARBONATE INJECTION, SOLUTION [US MEDSOURCE, LLC] 1 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 SODIUM BICARBONATE INJECTION, SOLUTION [US MEDSOURCE, LLC] 1 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM BICARBONATE INJECTION, SOLUTION [US MEDSOURCE, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-6625 SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250504_084f5572-8c1f-4802-b179-ca0cc838fc68.zip 0409-6625 SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250523_8664c7ce-707b-4c6c-9ce4-7160b5f877f8.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.
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 0409-6625-02 00409662502 25 VIAL in 1 TRAY (0409-6625-02) > 50 mL in 1 VIAL 25 vial 2005-03-31 2022-03-01 No No Current