sodium bicarbonate

Generic: sodium bicarbonate

Labeler: amneal pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sodium bicarbonate 84 mg/mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-2305
Product ID 80830-2305_31343ea0-9185-401b-83f2-f2ae7228bfe4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217523
Listing Expiration 2027-12-31
Marketing Start 2026-01-13

Pharmacologic Class

Classes
alkalinizing activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 808302305
Hyphenated Format 80830-2305

Supplemental Identifiers

RxCUI
1868486
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 ANDA217523 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 84 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2) / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1)
source: ndc

Packages (1)

80830-2305-2 25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2) / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1)

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": "31343ea0-9185-401b-83f2-f2ae7228bfe4", "openfda": {"unii": ["8MDF5V39QO"], "rxcui": ["1868486"], "spl_set_id": ["ba92f45a-0187-4709-aa70-462b8dae09e9"], "manufacturer_name": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2)  / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1)", "package_ndc": "80830-2305-2", "marketing_start_date": "20260113"}], "brand_name": "SODIUM BICARBONATE", "product_id": "80830-2305_31343ea0-9185-401b-83f2-f2ae7228bfe4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkalinizing Activity [MoA]"], "product_ndc": "80830-2305", "generic_name": "sodium bicarbonate", "labeler_name": "Amneal Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SODIUM BICARBONATE", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "84 mg/mL"}], "application_number": "ANDA217523", "marketing_category": "ANDA", "marketing_start_date": "20260113", "listing_expiration_date": "20271231"}