calcium gluconate (63323-360)

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 98 mg/mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-360

Product ID 63323-360_3e4a7e0e-c7f4-4aa0-8c9c-0aa3fd7dc729

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA208418

Listing Expiration 2026-12-31

Marketing Start 2017-06-15

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 63323360

Hyphenated Format 63323-360

Supplemental Identifiers

RxCUI

197435 1668248 1668250

UPC

0363323360016 0363323360054 0363323360030

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

98 mg/mL

source: ndc

Packaging

25 VIAL, PLASTIC in 1 TRAY (63323-360-19) / 10 mL in 1 VIAL, PLASTIC (63323-360-01)
25 VIAL, PLASTIC in 1 TRAY (63323-360-59) / 50 mL in 1 VIAL, PLASTIC (63323-360-03)
20 VIAL, PLASTIC in 1 TRAY (63323-360-61) / 100 mL in 1 VIAL, PLASTIC (63323-360-05)

source: ndc

Packages (3)

63323-360-19 25 VIAL, PLASTIC in 1 TRAY (63323-360-19) / 10 mL in 1 VIAL, PLASTIC (63323-360-01) 63323-360-59 25 VIAL, PLASTIC in 1 TRAY (63323-360-59) / 50 mL in 1 VIAL, PLASTIC (63323-360-03) 63323-360-61 20 VIAL, PLASTIC in 1 TRAY (63323-360-61) / 100 mL in 1 VIAL, PLASTIC (63323-360-05)

Ingredients (1)

calcium gluconate monohydrate (98 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": "3e4a7e0e-c7f4-4aa0-8c9c-0aa3fd7dc729", "openfda": {"upc": ["0363323360016", "0363323360054", "0363323360030"], "unii": ["CZN0MI5R31"], "rxcui": ["197435", "1668248", "1668250"], "spl_set_id": ["8b77c3d2-992d-4261-8421-9cfd07328fbf"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, PLASTIC in 1 TRAY (63323-360-19)  / 10 mL in 1 VIAL, PLASTIC (63323-360-01)", "package_ndc": "63323-360-19", "marketing_start_date": "20170615"}, {"sample": false, "description": "25 VIAL, PLASTIC in 1 TRAY (63323-360-59)  / 50 mL in 1 VIAL, PLASTIC (63323-360-03)", "package_ndc": "63323-360-59", "marketing_start_date": "20170615"}, {"sample": false, "description": "20 VIAL, PLASTIC in 1 TRAY (63323-360-61)  / 100 mL in 1 VIAL, PLASTIC (63323-360-05)", "package_ndc": "63323-360-61", "marketing_start_date": "20170615"}], "brand_name": "Calcium Gluconate", "product_id": "63323-360_3e4a7e0e-c7f4-4aa0-8c9c-0aa3fd7dc729", "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": "63323-360", "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": "98 mg/mL"}], "application_number": "NDA208418", "marketing_category": "NDA", "marketing_start_date": "20170615", "listing_expiration_date": "20261231"}