NDC 0498-0303

Miralac

Calcium Carbonate

Miralac is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Calcium Carbonate.

Product ID0498-0303_74f951e8-8401-fc5d-e053-2a91aa0a6b6f
NDC0498-0303
Product TypeHuman Otc Drug
Proprietary NameMiralac
Generic NameCalcium Carbonate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-02-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart331
Labeler NameHoneywell Safety Products USA, Inc
Substance NameCALCIUM CARBONATE
Active Ingredient Strength420 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0498-0303-10

100 PACKET in 1 BOX, UNIT-DOSE (0498-0303-10) > 2 TABLET in 1 PACKET
Marketing Start Date2012-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0498-0303-50 [00498030350]

Miralac TABLET
Marketing CategoryOTC monograph final
Application Numberpart331
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-22

NDC 0498-0303-10 [00498030310]

Miralac TABLET
Marketing CategoryOTC monograph final
Application Numberpart331
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-22

NDC 0498-0303-25 [00498030325]

Miralac TABLET
Marketing CategoryOTC monograph final
Application Numberpart331
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-22

Drug Details

Active Ingredients

IngredientStrength
CALCIUM CARBONATE420 mg/1

OpenFDA Data

SPL SET ID:7ccb324f-b12b-4867-87d5-b444e0c5b9a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198529
  • NDC Crossover Matching brand name "Miralac" or generic name "Calcium Carbonate"

    NDCBrand NameGeneric Name
    0498-0303MiralacMiralac
    0113-7489basic care antacidCalcium carbonate
    0113-7595basic care antacidCalcium Carbonate
    0054-3117Calcium CarbonateCalcium Carbonate
    0054-4120Calcium CarbonateCalcium Carbonate
    0054-8120Calcium CarbonateCalcium Carbonate
    0121-0766Calcium CarbonateCalcium Carbonate
    0121-4766Calcium CarbonateCalcium Carbonate
    0113-0009Good Sense Antacidcalcium carbonate
    0113-0179good sense antacidCalcium carbonate
    0113-0468good sense antacidCalcium carbonate
    0113-0478good sense antacidcalcium carbonate
    0113-0485good sense antacidcalcium carbonate
    0113-0489good sense antacidCalcium carbonate
    0113-0595good sense antacidCalcium Carbonate
    0113-0881Good Sense Antacidcalcium carbonate
    0113-0904good sense antacidCalcium carbonate
    0113-0962good sense antacidCalcium carbonate
    0135-0070TUMScalcium carbonate
    0135-0071TUMScalcium carbonate
    0135-0074TUMScalcium carbonate
    0135-0076TUMScalcium carbonate
    0135-0118TUMScalcium carbonate
    0135-0140TUMScalcium carbonate
    0135-0154TUMScalcium carbonate
    0135-0155TUMScalcium carbonate
    0135-0178TUMScalcium carbonate

    Trademark Results [Miralac]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MIRALAC
    MIRALAC
    86705272 not registered Live/Pending
    DigestSource, LLC
    2015-07-27

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