Home NDC 81298-7620 SODIUM BICARBONATE
Product NDC 81298-7620
11-digit product format 812987620
Labeler code 81298
Product ID 81298-7620_1a255946-a137-4e13-8203-65dd80b34872
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium bicarbonate injection,
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Long Grove Pharmaceuticals, LLC
Application ANDA216042
Marketing category ANDA
Marketing start 2024-09-30
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216042-001 SODIUM BICARBONATE SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216042-001 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.
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 A216042-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216042-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216042-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2024-02-27 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216042-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-02-27 a50c72e98297…
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 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 81298-7620-1 SODIUM BICARBONATE 50 mL in 1 VIAL SOLUTION 50 2 81298-7620-3 SODIUM BICARBONATE 20 in 1 CARTON SOLUTION 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81298-7620 SODIUM BICARBONATE (SODIUM BICARBONATE INJECTION,) SOLUTION [LONG GROVE PHARMACEUTICALS, LLC
] 2 Current NDC, 2 package rows 20241001_a26d709b-b294-4b02-9a88-7e840f099a33.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81298-7620-1 81298762001 50 mL in 1 VIAL 50 ml Historical 81298-7620-3 81298762003 20 VIAL in 1 CARTON (81298-7620-3) / 50 mL in 1 VIAL (81298-7620-1) 20 vial 2024-09-30 No No Current