NDC 70518-0653

Loratadine and Pseudoephedrine

Loratadine And Pseudoephedrine

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

Product ID70518-0653_55a2ff2e-bbe4-6e8f-e054-00144ff8d46c
NDC70518-0653
Product TypeHuman Otc Drug
Proprietary NameLoratadine and Pseudoephedrine
Generic NameLoratadine And Pseudoephedrine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA076557
Labeler NameREMEDYREPACK INC.
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength10 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0653-0

5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0653-0)
Marketing Start Date2017-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0653-0 [70518065300]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076557
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-31
Marketing End Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:af51f2ae-6f90-4cac-96e9-5faed3b07847
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1117562
  • NDC Crossover Matching brand name "Loratadine and Pseudoephedrine" or generic name "Loratadine And Pseudoephedrine"

    NDCBrand NameGeneric Name
    0363-0725Loratadine and PseudoephedrineLoratadine and Pseudoephedrine
    11822-9990Loratadine and PseudoephedrineLORATADINE and PSEUDOEPHEDRINE SULFATE
    21695-729Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    41163-165Loratadine and PseudoephedrineLoratadine and Pseudoephedrine
    46122-383Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    51660-488Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    51660-491Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    51660-724Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    61715-016Loratadine and PseudoephedrineLoratadine and Pseudoephedrine
    63187-305Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    63629-7766Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    70518-0653Loratadine and Pseudoephedrineloratadine and pseudoephedrine
    59779-726ALLERGY RELIEF-DLoratadine and Pseudoephedrine

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