NDC 49349-218

Loratadineantihistamine antihistamine

Loratadine

Loratadineantihistamine antihistamine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Loratadine.

Product ID49349-218_40edf56f-dd24-41e0-8002-986e2fd1e0a5
NDC49349-218
Product TypeHuman Prescription Drug
Proprietary NameLoratadineantihistamine antihistamine
Generic NameLoratadine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA076301
Labeler NameREMEDYREPACK INC.
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49349-218-20

100 TABLET in 1 VIAL (49349-218-20)
Marketing Start Date2013-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49349-218-02 [49349021802]

Loratadine Antihistamine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-01-12
Marketing End Date2016-07-06

NDC 49349-218-20 [49349021820]

Loratadine Antihistamine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-20
Inactivation Date2019-11-27

NDC 49349-218-57 [49349021857]

Loratadine Antihistamine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-11-10
Marketing End Date2016-07-06

NDC 49349-218-03 [49349021803]

Loratadine Antihistamine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-13
Marketing End Date2016-04-19

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:fa5ddd82-33ba-4cc8-a13f-1a866299367e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311372
  • NDC Crossover Matching brand name "Loratadineantihistamine antihistamine" or generic name "Loratadine"

    NDCBrand NameGeneric Name
    49349-218Loratadineantihistamine antihistamineLoratadineantihistamine antihistamine
    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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