NDC 0378-8880

Loratadine

Loratadine

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

Product ID0378-8880_1392dd15-842c-4689-87ba-caafc0503bca
NDC0378-8880
Product TypeHuman Otc Drug
Proprietary NameLoratadine
Generic NameLoratadine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA076154
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8880-10

1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)
Marketing Start Date2011-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8880-93 [00378888093]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076154
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-01
Marketing End Date2017-12-06

NDC 0378-8880-10 [00378888010]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076154
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-01

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:3b307aea-5a68-4c82-959a-cda4ffbd0a4a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311372
    • UPC Code
  • 0303788880100

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

    NDCBrand NameGeneric Name
    0179-8317LoratadineLoratadine
    0363-0522LoratadineLoratadine
    0363-0527LoratadineLoratadine
    0363-0752LoratadineLoratadine
    0363-9603LoratadineLoratadine
    68016-094LoratadineLoratadine
    68016-526LoratadineLoratadine
    68071-4121LoratadineLoratadine
    68071-3203LoratadineLoratadine
    68071-4451LoratadineLoratadine
    68084-248LoratadineLoratadine
    68788-7085LORATADINELORATADINE
    68788-7291LoratadineLoratadine
    68788-9805LoratadineLoratadine
    0536-1092LORATADINELORATADINE
    69452-211LORATADINELORATADINE
    69842-686LORATADINELORATADINE
    70000-0317LORATADINELORATADINE
    70000-0217LORATADINELORATADINE
    70000-0125LoratadineLoratadine
    70518-0325LoratadineLoratadine
    70518-1262LORATADINELORATADINE
    71335-0751LoratadineLoratadine
    71335-0888LoratadineLoratadine
    0615-5586LoratadineLoratadine
    0781-5077LoratadineLoratadine
    0904-5793LORATADINELORATADINE
    0904-6074LoratadineLoratadine
    0904-6234LoratadineLoratadine
    0904-6852LoratadineLoratadine
    10544-455LoratadineLoratadine
    11673-513LoratadineLoratadine
    11673-527LoratadineLoratadine
    11822-7240LORATADINELORATADINE
    15127-715LoratadineLoratadine
    15127-979LoratadineLoratadine
    16714-482LoratadineLoratadine
    17856-6234LoratadineLoratadine
    16714-898LoratadineLoratadine
    21130-526LoratadineLoratadine
    21695-499LoratadineLoratadine
    17856-0557LoratadineLoratadine
    21695-498LoratadineLoratadine
    24385-540LoratadineLoratadine
    25000-021loratadineloratadine
    24385-161LoratadineLoratadine
    36800-527LoratadineLoratadine
    37205-378LoratadineLoratadine
    37012-526LoratadineLoratadine
    41163-528LoratadineLoratadine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.