Home NDC 70518-4158 Sodium Bicarbonate
Product NDC 70518-4158
11-digit product format 705184158
Labeler code 70518
Product ID 70518-4158_3fb730ba-82fd-149f-e063-6394a90afa94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form INJECTION
Route INTRAVENOUS
Labeler REMEDYREPACK INC.
Application ANDA203449
Marketing category ANDA
Marketing start 2024-08-14
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 A203449-001 SODIUM BICARBONATE SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203449-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A203449-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203449-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203449-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2017-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203449-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2017-09-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 792582 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 70518-4158-0 Sodium Bicarbonate 50 mL in 1 SYRINGE INJECTION 50 4 70518-4158-0 Sodium Bicarbonate 1 in 1 CARTON INJECTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4158 SODIUM BICARBONATE INJECTION [REMEDYREPACK INC.] 3 Current NDC, 2 package rows 20250418_96093b76-5d98-4d2b-b851-20207a8864db.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 REMEDYREPACK INC. 96093b76-5d98-4d2b-b851-20207a8864db 2025-09-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203449 application number: ANDA203449 ndc (product): 70518-4158 Sodium Bicarbonate SODIUM BICARBONATE ProPharma Distribution 3d71b046-3e0b-054a-e063-6294a90a563a 2025-08-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203449 application number: ANDA203449 SODIUM BICARBONATE SODIUM BICARBONATE HF Acquisition Co LLC, DBA HealthFirst a5eedf57-2783-b3d0-e053-2a95a90a9ff5 2024-02-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203449 application number: ANDA203449 Sodium Bicarbonate SODIUM BICARBONATE Medical Purchasing Solutions, LLC b620938d-ab2d-0934-e053-2a95a90a8483 2023-05-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203449 application number: ANDA203449 Sodium Bicarbonate SODIUM BICARBONATE International Medication Systems, Limited 77698221-a01d-4568-a7bc-d3d4e982875d 2021-12-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203449 application number: ANDA203449
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4158-0 70518415800 1 SYRINGE in 1 CARTON (70518-4158-0) / 50 mL in 1 SYRINGE 1 syringe 2024-08-14 No No Current