sodium bicarbonate

Generic: sodium bicarbonate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium bicarbonate
Generic Name sodium bicarbonate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sodium bicarbonate 84 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-089
Product ID 63323-089_9def795c-abcf-483c-8b1d-e4374666efb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206688
Listing Expiration 2026-12-31
Marketing Start 2025-08-25

Pharmacologic Class

Classes
alkalinizing activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323089
Hyphenated Format 63323-089

Supplemental Identifiers

RxCUI
1868469 1868486
UPC
0363323089252 0363323083038
UNII
8MDF5V39QO

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sodium bicarbonate (source: ndc)
Generic Name sodium bicarbonate (source: ndc)
Application Number ANDA206688 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 84 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-089-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-089-25)
source: ndc

Packages (1)

63323-089-50 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-089-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-089-25)

Ingredients (1)

sodium bicarbonate (84 mg/mL)

Linked Drug Pages (1)

Sodium Bicarbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9def795c-abcf-483c-8b1d-e4374666efb2", "openfda": {"upc": ["0363323089252", "0363323083038"], "unii": ["8MDF5V39QO"], "rxcui": ["1868469", "1868486"], "spl_set_id": ["0ab55004-bb63-436d-ad77-cd3796905370"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-089-50)  / 50 mL in 1 VIAL, SINGLE-DOSE (63323-089-25)", "package_ndc": "63323-089-50", "marketing_start_date": "20250825"}], "brand_name": "Sodium Bicarbonate", "product_id": "63323-089_9def795c-abcf-483c-8b1d-e4374666efb2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkalinizing Activity [MoA]"], "product_ndc": "63323-089", "generic_name": "Sodium Bicarbonate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Bicarbonate", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "84 mg/mL"}], "application_number": "ANDA206688", "marketing_category": "ANDA", "marketing_start_date": "20250825", "listing_expiration_date": "20261231"}