NDC 70518-0371

Loratadine and Pseudoephedrine Sulfate

Loratadine And Pseudoephedrine Sulfate

Loratadine and Pseudoephedrine Sulfate is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Loratadine; Pseudoephedrine Sulfate.

Product ID70518-0371_83f0c56b-a556-cac6-e053-2a91aa0a67fd
NDC70518-0371
Product TypeHuman Otc Drug
Proprietary NameLoratadine and Pseudoephedrine Sulfate
Generic NameLoratadine And Pseudoephedrine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA076557
Labeler NameREMEDYREPACK INC.
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength10 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0371-0

15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-0371-0)
Marketing Start Date2017-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0371-0 [70518037100]

Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076557
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-29

NDC 70518-0371-1 [70518037101]

Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076557
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-12

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:6cc91178-bfde-4cbf-a3e0-1124ab5ff86a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1117562
  • NDC Crossover Matching brand name "Loratadine and Pseudoephedrine Sulfate" or generic name "Loratadine And Pseudoephedrine Sulfate"

    NDCBrand NameGeneric Name
    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
    68016-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    70518-0371Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    56062-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    62011-0071Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    63868-154Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine Sulfate
    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
    49614-172Medicine Shoppe Allergy Relief D24Loratadine and Pseudoephedrine Sulfate
    0363-2390Wal-itin DLoratadine and Pseudoephedrine Sulfate

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