NDC 52584-360

Calcium Gluconate

Calcium Gluconate

Calcium Gluconate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Calcium Gluconate Monohydrate.

Product ID52584-360_247dc1e8-daa7-40ac-a7ec-335b62cf6d86
NDC52584-360
Product TypeHuman Prescription Drug
Proprietary NameCalcium Gluconate
Generic NameCalcium Gluconate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-02-12
Marketing End Date2024-03-31
Marketing CategoryNDA / NDA
Application NumberNDA208418
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameCALCIUM GLUCONATE MONOHYDRATE
Active Ingredient Strength98 mg/mL
Pharm ClassesBlood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC Exclude FlagN

Packaging

NDC 52584-360-01

1 VIAL, PLASTIC in 1 BAG (52584-360-01) > 10 mL in 1 VIAL, PLASTIC
Marketing Start Date2018-02-15
Marketing End Date2023-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-360-01 [52584036001]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-15

NDC 52584-360-03 [52584036003]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-12

Drug Details

Active Ingredients

IngredientStrength
CALCIUM GLUCONATE MONOHYDRATE98 mg/mL

OpenFDA Data

SPL SET ID:22a5b168-acc0-43ea-a2b2-f3a1d220ac06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1668248
  • 1668250

    • Pharmacological Class

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