NDC 70000-0504

Leader Allergy Relief D12

Loratadine, Pseudoephedrine Sulfate

Leader Allergy Relief D12 is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Loratadine; Pseudoephedrine Sulfate.

Product ID70000-0504_2b1cd60c-0d7d-479f-9eee-1b251d13dd0b
NDC70000-0504
Product TypeHuman Otc Drug
Proprietary NameLeader Allergy Relief D12
Generic NameLoratadine, Pseudoephedrine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA076050
Labeler NameCardinal Health
Substance NameLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength5 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70000-0504-1

10 BLISTER PACK in 1 CARTON (70000-0504-1) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2020-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0504-2 [70000050402]

Leader Allergy Relief D12 TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076050
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-09

NDC 70000-0504-3 [70000050403]

Leader Allergy Relief D12 TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076050
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-09

NDC 70000-0504-1 [70000050401]

Leader Allergy Relief D12 TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076050
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-09

Drug Details

Active Ingredients

IngredientStrength
LORATADINE5 mg/1

NDC Crossover Matching brand name "Leader Allergy Relief D12" or generic name "Loratadine, Pseudoephedrine Sulfate"

NDCBrand NameGeneric Name
70000-0504Leader Allergy Relief D12Leader Allergy Relief D12
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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