NDC 44567-621

Calcium Gluconate

Calcium Gluconate

Calcium Gluconate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Wg Critical Care, Llc. The primary component is Calcium Gluconate Monohydrate.

Product ID44567-621_21ba26b6-6556-4abc-862a-2c5f46d530fe
NDC44567-621
Product TypeHuman Prescription Drug
Proprietary NameCalcium Gluconate
Generic NameCalcium Gluconate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-10-26
Marketing CategoryNDA / NDA
Application NumberNDA210906
Labeler NameWG Critical Care, LLC
Substance NameCALCIUM GLUCONATE MONOHYDRATE
Active Ingredient Strength20 mg/mL
Pharm ClassesBlood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 44567-621-24

24 POUCH in 1 CARTON (44567-621-24) > 1 BAG in 1 POUCH (44567-621-01) > 100 mL in 1 BAG
Marketing Start Date2018-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44567-621-24 [44567062124]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA210906
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-26

NDC 44567-621-01 [44567062101]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA210906
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-26

Drug Details

Active Ingredients

IngredientStrength
CALCIUM GLUCONATE MONOHYDRATE20 mg/mL

OpenFDA Data

SPL SET ID:e6d531ec-fcdc-49f6-b0c4-878d3952827f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2117608
  • 2117610

    • Pharmacological Class

    • Blood Coagulation Factor [EPC]
    • Increased Coagulation Factor Activity [PE]
    • Calcium [CS]
    • Cations
    • Divalent [CS]

    NDC Crossover Matching brand name "Calcium Gluconate" or generic name "Calcium Gluconate"

    NDCBrand NameGeneric Name
    0404-9831Calcium GluconateCalcium Gluconate
    0517-3900Calcium GluconateCalcium Gluconate
    0517-3950Calcium GluconateCalcium Gluconate
    44567-620Calcium GluconateCalcium Gluconate
    44567-621Calcium GluconateCalcium Gluconate
    44567-622Calcium GluconateCalcium Gluconate
    50090-2362Calcium GluconateCALCIUM GLUCONATE
    50090-3398Calcium GluconateCalcium Gluconate
    51662-1312CALCIUM GLUCONATECALCIUM GLUCONATE
    51662-1347CALCIUM GLUCONATECALCIUM GLUCONATE
    52584-360Calcium GluconateCalcium Gluconate
    63323-360Calcium GluconateCalcium Gluconate
    65219-162Calcium GluconateCalcium Gluconate
    65219-164Calcium GluconateCalcium Gluconate
    71872-7222Calcium GluconateCalcium Gluconate
    75834-171calcium gluconatecalcium gluconate
    0295-7520Calgonate Calcium Gluconate GelCalcium Gluconate
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.