sodium bicarbonate

Generic: sodium bicarbonate

Labeler: omnivium pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium bicarbonate
Generic Name sodium bicarbonate
Labeler omnivium pharmaceuticals llc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sodium bicarbonate 84 mg/mL

Manufacturer
OMNIVIUM PHARMACEUTICALS LLC.

Identifiers & Regulatory

Product NDC 81665-200
Product ID 81665-200_ada1be4a-11f4-4850-b98c-88e6ef02cd31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216364
Listing Expiration 2026-12-31
Marketing Start 2023-06-16

Pharmacologic Class

Classes
alkalinizing activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665200
Hyphenated Format 81665-200

Supplemental Identifiers

RxCUI
1868486
UPC
0381665200012
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 ANDA216364 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 84 mg/mL
source: ndc
Packaging
  • 20 VIAL in 1 CARTON (81665-200-05) / 50 mL in 1 VIAL (81665-200-01)
  • 25 VIAL in 1 CARTON (81665-200-25) / 50 mL in 1 VIAL (81665-200-01)
source: ndc

Packages (2)

81665-200-05 20 VIAL in 1 CARTON (81665-200-05) / 50 mL in 1 VIAL (81665-200-01) 81665-200-25 25 VIAL in 1 CARTON (81665-200-25) / 50 mL in 1 VIAL (81665-200-01)

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": "ada1be4a-11f4-4850-b98c-88e6ef02cd31", "openfda": {"upc": ["0381665200012"], "unii": ["8MDF5V39QO"], "rxcui": ["1868486"], "spl_set_id": ["aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc"], "manufacturer_name": ["OMNIVIUM PHARMACEUTICALS LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 VIAL in 1 CARTON (81665-200-05)  / 50 mL in 1 VIAL (81665-200-01)", "package_ndc": "81665-200-05", "marketing_start_date": "20230616"}, {"sample": false, "description": "25 VIAL in 1 CARTON (81665-200-25)  / 50 mL in 1 VIAL (81665-200-01)", "package_ndc": "81665-200-25", "marketing_start_date": "20230616"}], "brand_name": "Sodium Bicarbonate", "product_id": "81665-200_ada1be4a-11f4-4850-b98c-88e6ef02cd31", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkalinizing Activity [MoA]"], "product_ndc": "81665-200", "generic_name": "SODIUM BICARBONATE", "labeler_name": "OMNIVIUM PHARMACEUTICALS LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Bicarbonate", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "84 mg/mL"}], "application_number": "ANDA216364", "marketing_category": "ANDA", "marketing_start_date": "20230616", "listing_expiration_date": "20261231"}