NDC 11523-7162

Claritin-D 12 Hour

Loratadine And Pseudoephedrine Sulfate

Claritin-D 12 Hour is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Loratadine; Pseudoephedrine Sulfate.

Product ID11523-7162_54c41112-81bb-1475-e054-00144ff8d46c
NDC11523-7162
Product TypeHuman Otc Drug
Proprietary NameClaritin-D 12 Hour
Generic NameLoratadine And Pseudoephedrine Sulfate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-12-01
Marketing CategoryNDA / NDA
Application NumberNDA019670
Labeler NameBayer HealthCare LLC.
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength5 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11523-7162-1

1 BLISTER PACK in 1 CARTON (11523-7162-1) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2009-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-7162-1 [11523716201]

Claritin-D 12 Hour TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019670
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-12-01

NDC 11523-7162-3 [11523716203]

Claritin-D 12 Hour TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019670
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-12-01

NDC 11523-7162-2 [11523716202]

Claritin-D 12 Hour TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019670
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-12-01

Drug Details

Active Ingredients

IngredientStrength
LORATADINE5 mg/1

OpenFDA Data

SPL SET ID:a7125705-01ff-4418-8c53-9209c2bbb484
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1242406
  • 1242399
  • UPC Code
  • 0041100802088
  • Medicade Reported Pricing

    11523716203 CLARITIN-D 12 HOUR TABLET

    Pricing Unit: EA | Drug Type:

    11523716202 CLARITIN-D 12 HOUR TABLET

    Pricing Unit: EA | Drug Type:

    11523716201 CLARITIN-D 12 HOUR TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Claritin-D 12 Hour" or generic name "Loratadine And Pseudoephedrine Sulfate"

    NDCBrand NameGeneric Name
    37012-239Allergy Relief-DLoratadine and Pseudoephedrine Sulfate
    41250-239Allergy Relief-DLoratadine and Pseudoephedrine Sulfate
    36800-472Allergy Relief-D24 HourLoratadine and Pseudoephedrine Sulfate
    11523-4332Claritin-DLoratadine and pseudoephedrine sulfate
    11523-7162Claritin-DLoratadine and pseudoephedrine sulfate
    37205-348Leader Allergy Relief D-24Loratadine and Pseudoephedrine Sulfate
    11822-9990Loratadine and PseudoephedrineLORATADINE and PSEUDOEPHEDRINE SULFATE
    0904-5833Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    11673-165Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    15127-717Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    21130-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    30142-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    36800-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    37012-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    37808-427Loratadine and Pseudoephedrine Sulfateloratadine and pseudoephedrine sulfate
    37808-724Loratadine and Pseudoephedrine Sulfateloratadine and pseudoephedrine sulfate
    41250-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    46122-167Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    49035-488Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    49348-543Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    49614-172Medicine Shoppe Allergy Relief D24Loratadine and Pseudoephedrine Sulfate
    0363-2390Wal-itin DLoratadine and Pseudoephedrine Sulfate

    Trademark Results [Claritin-D]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLARITIN-D
    CLARITIN-D
    76506212 2819388 Live/Registered
    BAYER HEALTHCARE LLC
    2003-04-14
    CLARITIN-D
    CLARITIN-D
    74659413 1960278 Dead/Cancelled
    Schering Corporation
    1995-04-05
    CLARITIN-D
    CLARITIN-D
    74475937 1912214 Live/Registered
    BAYER HEALTHCARE LLC
    1994-01-03

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.