NDC 11523-4359

Claritin

Loratadine

Claritin is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Loratadine.

Product ID11523-4359_8242a0ef-e3e8-8e01-e053-2a91aa0abdc9
NDC11523-4359
Product TypeHuman Otc Drug
Proprietary NameClaritin
Generic NameLoratadine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1993-04-12
Marketing CategoryNDA / NDA
Application NumberNDA019658
Labeler NameBayer HealthCare LLC.
Substance NameLORATADINE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11523-4359-1

1 BOTTLE in 1 CARTON (11523-4359-1) > 40 TABLET in 1 BOTTLE
Marketing Start Date1993-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-4359-6 [11523435906]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-01

NDC 11523-4359-2 [11523435902]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-12

NDC 11523-4359-1 [11523435901]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-12

NDC 11523-4359-9 [11523435909]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-01

NDC 11523-4359-4 [11523435904]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-15

NDC 11523-4359-8 [11523435908]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-12

NDC 11523-4359-3 [11523435903]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-01

NDC 11523-4359-5 [11523435905]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-15

NDC 11523-4359-7 [11523435907]

Claritin TABLET
Marketing CategoryNDA
Application NumberNDA019658
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-12

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:660ac9df-f1b1-4c89-94dd-9fae0a013f3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311372
  • 206805
  • UPC Code
  • 0041100808707
  • 0041100806147