FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
80830-2613
Requested package NDC
80830-2613-2
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220790-001SODIUM BICARBONATESODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220790-001SODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-0984e616aacf4f…
2026-08-18 06:07:402026-07N220790-001SODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-09caaa826d4ba7…

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
ac91e834-e693-43a2-829b-56793453e8ccAvailable 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 BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 220790
application number: NDA220790
ndc (package): 80830-2613-2
ndc (product): 80830-2613
ndc11 (package): 80830261302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80830-2613-2808302613026 POUCH in 1 CARTON (80830-2613-2) / 1 BAG in 1 POUCH (80830-2613-1) / 1000 mL in 1 BAG6 pouch2026-07-13NoNoCurrent