FDA.reportPublic FDA data

sodium bicarbonate

Product NDC
0338-0822
Requested package NDC
0338-0822-10
11-digit product format
003380822
Labeler code
0338
Product ID
0338-0822_b50c858a-00c8-4cb2-ad73-8797f19e656d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium bicarbonate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA218524
Marketing category
NDA
Marketing start
2026-08-14
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218524-001SODIUM BICARBONATESODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)SOLUTION / INTRAVENOUSRLD, RS2026-08-14

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
2026-09-14 22:38:342026-08N218524-001SODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)SOLUTION / INTRAVENOUSRLD, RS2026-08-1484e616aacf4f…

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
IngredientStrength
SODIUM BICARBONATE12.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747138Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b50c858a-00c8-4cb2-ad73-8797f19e656dAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 218524
application number: NDA218524
ndc (package): 0338-0822-10
ndc (product): 0338-0822
ndc11 (package): 00338082210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-0822-100033808221010 BAG in 1 CARTON (0338-0822-10) / 1000 mL in 1 BAG10 bag2026-08-14NoNoCurrent