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 98 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-630
Product ID 65219-630_166681fc-9f43-470d-81e2-ff8be7cd39dc
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 65219630
Hyphenated Format 65219-630

Supplemental Identifiers

RxCUI
1668250
UPC
0365219630012
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 (65219-630-19) / 10 mL in 1 VIAL, PLASTIC (65219-630-01)
source: ndc

Packages (1)

65219-630-19 25 VIAL, PLASTIC in 1 TRAY (65219-630-19) / 10 mL in 1 VIAL, PLASTIC (65219-630-01)

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": "166681fc-9f43-470d-81e2-ff8be7cd39dc", "openfda": {"upc": ["0365219630012"], "unii": ["CZN0MI5R31"], "rxcui": ["1668250"], "spl_set_id": ["1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, PLASTIC in 1 TRAY (65219-630-19)  / 10 mL in 1 VIAL, PLASTIC (65219-630-01)", "package_ndc": "65219-630-19", "marketing_start_date": "20170615"}], "brand_name": "Calcium Gluconate", "product_id": "65219-630_166681fc-9f43-470d-81e2-ff8be7cd39dc", "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": "65219-630", "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"}