NDC 0363-1133

12 hour allergy and congestion

Loratadine, Pseudoephedrine Sulfate

12 hour allergy and congestion is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Loratadine; Pseudoephedrine Sulfate.

Product ID0363-1133_162c022f-b102-4b52-98de-8989362ffb10
NDC0363-1133
Product TypeHuman Otc Drug
Proprietary Name12 hour allergy and congestion
Generic NameLoratadine, Pseudoephedrine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA076050
Labeler NameWalgreen Company
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength5 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0363-1133-46

10 BLISTER PACK in 1 CARTON (0363-1133-46) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-1133-60 [00363113360]

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

NDC 0363-1133-46 [00363113346]

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

NDC 0363-1133-65 [00363113365]

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

Drug Details

Active Ingredients

IngredientStrength
LORATADINE5 mg/1

OpenFDA Data

SPL SET ID:642727e6-9e47-4821-a4bc-d8fa773b0086
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1242399

    • NDC Crossover Matching brand name "12 hour allergy and congestion" or generic name "Loratadine, Pseudoephedrine Sulfate"

    NDCBrand NameGeneric Name
    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
    36800-611topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate
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