NDC 63323-360

Calcium Gluconate

Calcium Gluconate

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

Product ID63323-360_35d0c893-641d-4dcf-aabf-0041dd1ab8e1
NDC63323-360
Product TypeHuman Prescription Drug
Proprietary NameCalcium Gluconate
Generic NameCalcium Gluconate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-15
Marketing CategoryNDA / NDA
Application NumberNDA208418
Labeler NameFresenius Kabi USA, LLC
Substance NameCALCIUM GLUCONATE MONOHYDRATE
Active Ingredient Strength98 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 63323-360-19

25 VIAL, PLASTIC in 1 TRAY (63323-360-19) > 10 mL in 1 VIAL, PLASTIC (63323-360-01)
Marketing Start Date2017-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-360-03 [63323036003]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-15

NDC 63323-360-05 [63323036005]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-15

NDC 63323-360-59 [63323036059]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-15

NDC 63323-360-01 [63323036001]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-15

NDC 63323-360-61 [63323036061]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-15

NDC 63323-360-19 [63323036019]

Calcium Gluconate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-15

Drug Details

Active Ingredients

IngredientStrength
CALCIUM GLUCONATE MONOHYDRATE98 mg/mL

OpenFDA Data

SPL SET ID:8b77c3d2-992d-4261-8421-9cfd07328fbf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1668248
  • 197435
  • 1668250

    • 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
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