calcium gluconate

Generic: calcium gluconate

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

Drug Facts

Product Profile

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

calcium gluconate monohydrate 20 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-164
Product ID 65219-164_3351b72a-aa15-419f-a58c-4df90573d9f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208418
Listing Expiration 2026-12-31
Marketing Start 2021-06-17

Pharmacologic Class

Classes
blood coagulation factor [epc] calcium [cs] cations divalent [cs] increased coagulation factor activity [pe] phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219164
Hyphenated Format 65219-164

Supplemental Identifiers

RxCUI
2117608 2117610
UNII
CZN0MI5R31

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 calcium gluconate (source: ndc)
Generic Name calcium gluconate (source: ndc)
Application Number NDA208418 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CASE (65219-164-50) / 100 mL in 1 BAG (65219-164-01)
source: ndc

Packages (1)

65219-164-50 24 BAG in 1 CASE (65219-164-50) / 100 mL in 1 BAG (65219-164-01)

Ingredients (1)

calcium gluconate monohydrate (20 mg/mL)

Linked Drug Pages (1)

Calcium Gluconate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3351b72a-aa15-419f-a58c-4df90573d9f9", "openfda": {"unii": ["CZN0MI5R31"], "rxcui": ["2117608", "2117610"], "spl_set_id": ["7f5101e0-abf9-4fcf-8986-c799e3333434"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CASE (65219-164-50)  / 100 mL in 1 BAG (65219-164-01)", "package_ndc": "65219-164-50", "marketing_start_date": "20210617"}], "brand_name": "Calcium Gluconate", "product_id": "65219-164_3351b72a-aa15-419f-a58c-4df90573d9f9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Blood Coagulation Factor [EPC]", "Calcium [CS]", "Cations", "Divalent [CS]", "Increased Coagulation Factor Activity [PE]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "65219-164", "generic_name": "Calcium Gluconate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcium Gluconate", "active_ingredients": [{"name": "CALCIUM GLUCONATE MONOHYDRATE", "strength": "20 mg/mL"}], "application_number": "NDA208418", "marketing_category": "NDA", "marketing_start_date": "20210617", "listing_expiration_date": "20261231"}