NDC 68788-7653

Loratadine

Loratadine

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

Product ID68788-7653_4e22fb1a-f06f-4912-9f59-c411c73b1a0b
NDC68788-7653
Product TypeHuman Otc Drug
Proprietary NameLoratadine
Generic NameLoratadine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA076301
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68788-7653-0

10 TABLET in 1 BOTTLE (68788-7653-0)
Marketing Start Date2020-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7653-5 [68788765305]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-28

NDC 68788-7653-9 [68788765309]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-28

NDC 68788-7653-1 [68788765301]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-28

NDC 68788-7653-3 [68788765303]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-28

NDC 68788-7653-0 [68788765300]

Loratadine TABLET
Marketing CategoryANDA
Application NumberANDA076301
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:8cf58067-8805-423a-b1aa-cfe28641a215
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311372
  • 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.