NDC 36800-611

topcare allergy and congestion relief

Loratadine, Pseudoephedrine Sulfate

topcare allergy and congestion relief is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Loratadine; Pseudoephedrine Sulfate.

Product ID36800-611_47f02151-689c-4592-ab13-6c4e259d7a6c
NDC36800-611
Product TypeHuman Otc Drug
Proprietary Nametopcare allergy and congestion relief
Generic NameLoratadine, Pseudoephedrine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA076050
Labeler NameTopco Associates LLC
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesAdrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-611-65

30 BLISTER PACK in 1 CARTON (36800-611-65) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-611-65 [36800061165]

topcare allergy and congestion relief TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076050
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-05-18

Drug Details

Active Ingredients

IngredientStrength
LORATADINE5 mg/1

OpenFDA Data

SPL SET ID:dd93d172-2a3a-4e4c-a237-7668acbd537d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1242399

    • NDC Crossover Matching brand name "topcare allergy and congestion relief" or generic name "Loratadine, Pseudoephedrine Sulfate"

    NDCBrand NameGeneric Name
    36800-611topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate
    0363-113312 hour allergy and congestionloratadine, Pseudoephedrine sulfate
    0573-2660ALAVERT ALLERGY SINUS D-12loratadine, pseudoephedrine sulfate
    0113-2007Allergy and Congestion Reliefloratadine, Pseudoephedrine sulfate
    11822-1019allergy and congestion reliefloratadine, Pseudoephedrine sulfate
    30142-786allergy and congestion reliefloratadine, Pseudoephedrine sulfate
    11822-1055Allergy Relief Dloratadine, Pseudoephedrine sulfate
    41250-954allergy relief dloratadine, Pseudoephedrine sulfate
    56062-555allergy relief dloratadine, Pseudoephedrine sulfate
    0363-7023allergy relief d 12loratadine, Pseudoephedrine sulfate
    41520-918careone allergy and congestion reliefloratadine, Pseudoephedrine sulfate
    41163-861equaline allergy and congestion reliefloratadine, Pseudoephedrine sulfate
    49035-643equate allergy and congestion reliefloratadine, pseudoephedrine sulfate
    46122-455good neighbor pharmacy loratadine dloratadine, Pseudoephedrine sulfate
    0113-1165good sense allergy and congestion reliefLoratadine, Pseudoephedrine Sulfate
    62011-0354health mart allergy and congestionloratadine, Pseudoephedrine sulfate
    45802-122loratadine Dloratadine, Pseudoephedrine sulfate
    0113-7777perrigo allergy dloratadine, Pseudoephedrine sulfate
    21130-482signature care allergy and congestion reliefloratadine, Pseudoephedrine sulfate
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