Home NDC 68462-951 SODIUM BICARBONATE
Product NDC 68462-951
11-digit product format 684620951
Labeler code 68462
Product ID 68462-951_f38d0dfc-9bcc-4224-a202-885c9ad0beae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM BICARBONATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA219701
Marketing category ANDA
Marketing start 2025-08-07
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 A219701-001 SODIUM BICARBONATE SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219701-001 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 2026-08-18 06:07:40 2026-07 A219701-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219701-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219701-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219701-001 SODIUM BICARBONATE 1MEQ/ML INJECTABLE / INJECTION AP 2025-06-26 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219701-001 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-06-26 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 68462-951-50 SODIUM BICARBONATE 50 mL in 1 VIAL INJECTION, SOLUTION 50 1 68462-951-65 SODIUM BICARBONATE 25 in 1 CARTON INJECTION, SOLUTION 25 1
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 · 3 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 68462-951-50 68462095150 50 mL in 1 VIAL 50 ml Historical 68462-951-65 68462095165 25 VIAL in 1 CARTON (68462-951-65) / 50 mL in 1 VIAL (68462-951-50) 25 vial 2025-08-07 No No Current