NDC 25000-021

Loratadine

Loratadine

Loratadine is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Marksans Pharma Limited. The primary component is Loratadine.

Product ID25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f
NDC25000-021
Product TypeHuman Otc Drug
Proprietary NameLoratadine
Generic NameLoratadine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA206214
Labeler NameMARKSANS PHARMA LIMITED
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 25000-021-08

100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08)
Marketing Start Date2016-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25000-021-08 [25000002108]

loratadine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206214
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-01

NDC 25000-021-46 [25000002146]

loratadine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206214
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-01

NDC 25000-021-34 [25000002134]

loratadine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206214
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-01

NDC 25000-021-13 [25000002113]

loratadine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206214
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-01

NDC 25000-021-21 [25000002121]

loratadine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206214
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-01

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:c30907f9-1761-41e5-bd4e-2613e756e1c6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828269
    • UPC Code
  • 0325000021344

    • 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
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