NDC 58602-821

Loratadine ODT

Loratadine

Loratadine ODT is a Oral Tablet, Orally Disintegrating in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Loratadine.

Product ID58602-821_7564581a-2a15-4c0e-8ae9-459a760613a9
NDC58602-821
Product TypeHuman Otc Drug
Proprietary NameLoratadine ODT
Generic NameLoratadine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2018-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA208477
Labeler NameAurohealth LLC
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 58602-821-83

1 BLISTER PACK in 1 CARTON (58602-821-83) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2018-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-821-83 [58602082183]

Loratadine ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA208477
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-11

NDC 58602-821-84 [58602082184]

Loratadine ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA208477
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-11

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:9f44382f-c289-402d-bb98-ec5fa80fc25d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311373
    • UPC Code
  • 0358602821838

    • NDC Crossover Matching brand name "Loratadine ODT" or generic name "Loratadine"

    NDCBrand NameGeneric Name
    68016-088Loratadine ODTLoratadine ODT
    68016-527Loratadine ODTLoratadine ODT
    69842-085Loratadine ODTLoratadine ODT
    0904-5806Loratadine ODTLoratadine ODT
    21130-527Loratadine ODTLoratadine ODT
    36800-528Loratadine ODTLoratadine ODT
    37012-527Loratadine ODTLoratadine ODT
    41250-527Loratadine ODTLoratadine ODT
    41250-513Loratadine ODTLoratadine ODT
    46122-539Loratadine ODTLoratadine ODT
    49035-806Loratadine ODTLoratadine ODT
    53943-035Loratadine ODTLoratadine ODT
    58602-744Loratadine ODTLoratadine ODT
    58602-821Loratadine ODTLoratadine ODT
    58602-830Loratadine ODTLoratadine ODT
    59779-527Loratadine ODTLoratadine ODT
    60000-950Loratadine ODTLoratadine ODT
    0363-9937Loratadine ODTLoratadine ODT
    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

    Trademark Results [Loratadine ODT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LORATADINE ODT
    LORATADINE ODT
    76601213 not registered Dead/Abandoned
    LEINER HEALTH SERVICES CORP.
    2004-07-08
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.