Home NDC 63323-083 Sodium Bicarbonate
Product NDC 63323-083
11-digit product format 633230083
Labeler code 63323
Product ID 63323-083_9def795c-abcf-483c-8b1d-e4374666efb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA206688
Marketing category ANDA
Marketing start 2025-08-25
Substance SODIUM BICARBONATE
Active strength 42 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206688-001 SODIUM BICARBONATE SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 A206688-002 SODIUM BICARBONATE SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A206688-001 SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206688-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206688-001 SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206688-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206688-001 SODIUM BICARBONATE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206688-002 SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-08-25 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1868469 Internal RxNorm lookup 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 63323-083-03 Sodium Bicarbonate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 8 63323-083-05 Sodium Bicarbonate 25 in 1 TRAY INJECTION, SOLUTION 25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-083 SODIUM BICARBONATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250322_0ab55004-bb63-436d-ad77-cd3796905370.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 Marketing end Sample Exclude flag Status 63323-083-03 63323008303 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 63323-083-05 63323008305 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-083-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03) 2025-08-25 0000-00-00 No No Current