Home NDC 80830-2613 Sodium Bicarbonate
Product NDC 80830-2613
11-digit product format 808302613
Labeler code 80830
Product ID 80830-2613_28e698ac-0138-47d1-8ab1-9e29c2ad743a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals Private Limited
Application NDA220790
Marketing category NDA
Marketing start 2026-07-13
Substance SODIUM BICARBONATE
Active strength 12.6 mg/mL
Pharmacologic classes Alkalinizing Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 N220790-001 SODIUM BICARBONATE SODIUM BICARBONATE 150MEQ/1000ML (0.15MEQ/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-07-09
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 2026-09-14 22:38:34 2026-08 N220790-001 SODIUM BICARBONATE 150MEQ/1000ML (0.15MEQ/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220790-001 SODIUM BICARBONATE 150MEQ/1000ML (0.15MEQ/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-07-09 caaa826d4ba7…
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 12.6 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 2747138 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80830-2613-2 80830261302 6 POUCH in 1 CARTON (80830-2613-2) / 1 BAG in 1 POUCH (80830-2613-1) / 1000 mL in 1 BAG 6 pouch 2026-07-13 No No Current