NDC 0904-6767

Childrens Loratadine Oral

Loratadine

Childrens Loratadine Oral is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Loratadine.

Product ID0904-6767_3f0f0131-b516-4ff3-8049-3d3766324b66
NDC0904-6767
Product TypeHuman Otc Drug
Proprietary NameChildrens Loratadine Oral
Generic NameLoratadine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-02-12
Marketing CategoryANDA / ANDA
Application NumberANDA075728
Labeler NameMajor Pharmaceuticals
Substance NameLORATADINE
Active Ingredient Strength5 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6767-20

1 BOTTLE in 1 CARTON (0904-6767-20) > 120 mL in 1 BOTTLE
Marketing Start Date2019-02-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6767-20 [00904676720]

Childrens Loratadine Oral SOLUTION
Marketing CategoryANDA
Application NumberANDA075728
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-02-12

Drug Details

Active Ingredients

IngredientStrength
LORATADINE5 mg/5mL

OpenFDA Data

SPL SET ID:3f0f0131-b516-4ff3-8049-3d3766324b66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 692783
  • NDC Crossover Matching brand name "Childrens Loratadine Oral" or generic name "Loratadine"

    NDCBrand NameGeneric Name
    0904-6767Childrens Loratadine OralChildrens Loratadine Oral
    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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