NDC 21695-729

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 Rebel Distributors Corp. The primary component is Loratadine; Pseudoephedrine Sulfate.

Product ID21695-729_72335a37-d685-457c-a431-fd81e4ad9168
NDC21695-729
Product TypeHuman Otc Drug
Proprietary NameLoratadine and Pseudoephedrine
Generic NameLoratadine And Pseudoephedrine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2004-11-17
Marketing CategoryANDA / ANDA
Application NumberANDA076557
Labeler NameRebel Distributors Corp
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength10 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-729-05

5 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-729-05)
Marketing Start Date2004-11-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-729-10 [21695072910]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076557
Product TypeHUMAN OTC DRUG
Marketing Start Date2004-11-17
Inactivation Date2019-09-24

NDC 21695-729-05 [21695072905]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076557
Product TypeHUMAN OTC DRUG
Marketing Start Date2004-11-17
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
LORATADINE10 mg/1

OpenFDA Data

SPL SET ID:72335a37-d685-457c-a431-fd81e4ad9168
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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