sodium bicarbonate

Generic: sodium bicarbonate

Labeler: exela pharma sciences, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium bicarbonate
Generic Name sodium bicarbonate
Labeler exela pharma sciences, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sodium bicarbonate 84 mg/mL

Manufacturer
Exela Pharma Sciences, LLC

Identifiers & Regulatory

Product NDC 51754-5011
Product ID 51754-5011_4da0ba66-756d-4b4d-8018-81ca16578ef1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211091
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

Pharmacologic Class

Classes
alkalinizing activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 517545011
Hyphenated Format 51754-5011

Supplemental Identifiers

RxCUI
807284 1868486 1923484 2198792
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 ANDA211091 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 84 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (51754-5011-4) / 10 mL in 1 VIAL
source: ndc

Packages (1)

51754-5011-4 25 VIAL in 1 CARTON (51754-5011-4) / 10 mL in 1 VIAL

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": "4da0ba66-756d-4b4d-8018-81ca16578ef1", "openfda": {"unii": ["8MDF5V39QO"], "rxcui": ["807284", "1868486", "1923484", "2198792"], "spl_set_id": ["e9698a4f-1a95-4f28-a945-e8009d1d6dd4"], "manufacturer_name": ["Exela Pharma Sciences, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (51754-5011-4)  / 10 mL in 1 VIAL", "package_ndc": "51754-5011-4", "marketing_start_date": "20200901"}], "brand_name": "Sodium Bicarbonate", "product_id": "51754-5011_4da0ba66-756d-4b4d-8018-81ca16578ef1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkalinizing Activity [MoA]"], "product_ndc": "51754-5011", "generic_name": "SODIUM BICARBONATE", "labeler_name": "Exela Pharma Sciences, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Bicarbonate", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "84 mg/mL"}], "application_number": "ANDA211091", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}