FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
52584-637
11-digit product format
525840637
Labeler code
52584
Product ID
52584-637_8b23d518-fb32-4b47-a241-26ff0aa58dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
ANDA077394
Marketing category
ANDA
Marketing start
2010-08-01
Marketing end
2022-04-01
Substance
SODIUM BICARBONATE
Active strength
84 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52584-637DDiscontinued by firm2026-08-03
excluded packagepackage52584-63752584-637-34DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077394-001SODIUM BICARBONATESODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML)SOLUTION / INTRAVENOUS2005-11-09
A077394-002SODIUM BICARBONATESODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUS2005-11-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077394-001SODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML)SOLUTION / INTRAVENOUS2005-11-09a50c72e98297…
2026-08-01 22:54:322026-06A077394-002SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUS2005-11-09a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QOSODIUM BICARBONATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
Sodium CationACTIVE MOIETYLYR4M0NH37SODIUM BICARBONATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-637-34525840637341 BOX in 1 BAG (52584-637-34) > 1 SYRINGE, GLASS in 1 BOX > 50 mL in 1 SYRINGE, GLASS1 box2010-08-010000-00-00NoNoCurrent