NDC 53041-285

Guardian Loratadine

Loratadine

Guardian Loratadine is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Loratadine.

Product ID53041-285_af8cdd37-8fd0-4651-ae03-36c7d4863301
NDC53041-285
Product TypeHuman Otc Drug
Proprietary NameGuardian Loratadine
Generic NameLoratadine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA207569
Labeler NameGuardian Drug Company
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53041-285-21

1000 TABLET in 1 BOTTLE (53041-285-21)
Marketing Start Date2019-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53041-285-21 [53041028521]

Guardian Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA207569
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-22

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:af8cdd37-8fd0-4651-ae03-36c7d4863301
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311372
  • NDC Crossover Matching brand name "Guardian Loratadine" or generic name "Loratadine"

    NDCBrand NameGeneric Name
    53041-285Guardian LoratadineGuardian Loratadine
    0363-1612allergy reliefLoratadine
    0113-7612Basic Care allergy reliefLoratadine
    0113-7500basic care childrens allergy reliefloratadine
    0113-7671Basic Care Childrens Allergy ReliefLoratadine
    0121-0849Childrens LoratadineLORATADINE
    0363-2131Childrens LoratadineLoratadine
    0363-4020CHILDRENS LORATADINE ODTLoratadine
    0363-2092Childrens Wal-itinLoratadine
    0363-2108Childrens WalitinLoratadine
    0113-0612good sense allergy reliefLoratadine
    0113-1191good sense allergy reliefloratadine
    0113-1612good sense allergy reliefLoratadine
    0113-9755good sense allergy reliefloratadine
    0113-0671Good Sense childrens allergy reliefLoratadine
    0113-1019good sense childrens allergy reliefloratadine
    0113-1719good sense childrens allergy reliefLoratadine
    0363-0858Indoor Outdoor Allergy ReliefLoratadine
    0179-8317LoratadineLoratadine
    0363-0522LoratadineLoratadine
    0363-0527LoratadineLoratadine
    0363-0752LoratadineLoratadine
    0363-9603LoratadineLoratadine
    0363-0699Wal itinLoratadine
    0363-0754Wal-itinLORATADINE
    0363-1686WAL-ITINLORATADINE
    0363-9150Wal-itinLoratadine
    0363-2085Wal-itin Allergy ReliefLoratadine

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