sodium bicarbonate

Generic: sodium bicarbonate

Labeler: anthea pharma private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium bicarbonate
Generic Name sodium bicarbonate
Labeler anthea pharma private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sodium bicarbonate 84 mg/mL

Manufacturer
Anthea Pharma Private Limited

Identifiers & Regulatory

Product NDC 83854-001
Product ID 83854-001_38887da2-9f53-8db2-e063-6294a90a7738
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219701
Listing Expiration 2026-12-31
Marketing Start 2025-06-26

Pharmacologic Class

Classes
alkalinizing activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83854001
Hyphenated Format 83854-001

Supplemental Identifiers

RxCUI
1868486
UPC
0383854001011
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 ANDA219701 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 84 mg/mL
source: ndc
Packaging
  • 20 VIAL in 1 CARTON (83854-001-20) / 50 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (83854-001-25) / 50 mL in 1 VIAL
source: ndc

Packages (2)

83854-001-20 20 VIAL in 1 CARTON (83854-001-20) / 50 mL in 1 VIAL 83854-001-25 25 VIAL in 1 CARTON (83854-001-25) / 50 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": "38887da2-9f53-8db2-e063-6294a90a7738", "openfda": {"upc": ["0383854001011"], "unii": ["8MDF5V39QO"], "rxcui": ["1868486"], "spl_set_id": ["0df8cf62-4b49-4ec4-aae4-c4a3e6d76549"], "manufacturer_name": ["Anthea Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 VIAL in 1 CARTON (83854-001-20)  / 50 mL in 1 VIAL", "package_ndc": "83854-001-20", "marketing_start_date": "20250626"}, {"sample": false, "description": "25 VIAL in 1 CARTON (83854-001-25)  / 50 mL in 1 VIAL", "package_ndc": "83854-001-25", "marketing_start_date": "20250626"}], "brand_name": "SODIUM BICARBONATE", "product_id": "83854-001_38887da2-9f53-8db2-e063-6294a90a7738", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkalinizing Activity [MoA]"], "product_ndc": "83854-001", "generic_name": "SODIUM BICARBONATE", "labeler_name": "Anthea Pharma Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SODIUM BICARBONATE", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "84 mg/mL"}], "application_number": "ANDA219701", "marketing_category": "ANDA", "marketing_start_date": "20250626", "listing_expiration_date": "20261231"}