NDC 63187-955

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Cetirizine Hcl, Pseudoephedrine Hcl

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride.

Product ID63187-955_0a08231c-188b-4c9a-8680-d43152d71983
NDC63187-955
Product TypeHuman Otc Drug
Proprietary NameCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Generic NameCetirizine Hcl, Pseudoephedrine Hcl
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-04-10
Marketing CategoryANDA / ANDA
Application NumberANDA077170
Labeler NameProficient Rx LP
Substance NameCETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63187-955-12

12 BLISTER PACK in 1 CARTON (63187-955-12) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-955-12 [63187095512]

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077170
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01

NDC 63187-955-24 [63187095524]

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077170
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:5d91286c-5650-462f-bd3d-f3b2387afcde
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014571

    • NDC Crossover Matching brand name "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride" or generic name "Cetirizine Hcl, Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    45802-147Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCetirizine hydrochloride, Pseudoephedrine hydrochloride
    45802-721Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HCl
    68258-8907Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    50090-1098Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    63187-955Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    63868-964Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    41250-29912 hour allergy dCetirizine HCl, Pseudoephedrine HCl
    0904-5831All day Allergy dCetirizine HCl, Pseudoephedrine HCl
    30142-176all day allergy dCetirizine HCl, Pseudoephedrine HCl
    42507-176All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    37808-176all day Allergy Relief DCetirizine HCl, Pseudoephedrine HCl
    0113-2176All Day Allergy-DCetirizine HCl, Pseudoephedrine HCl
    11822-0566allergy and congestion relief dCetirizine HCl, Pseudoephedrine HCl
    37012-176Allergy Relief DCetirizine HCl, Pseudoephedrine HCl
    37808-785allergy relief dCetirizine HCl, Pseudoephedrine HCl
    49035-982Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    41520-355CareOne All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    41520-091CareOne Allergy Relief DCetirizine HCl, Pseudoephedrine HCl
    41163-176Equaline All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    24385-175Good Neighbor Pharmacy All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    0113-0176Good Sense All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    37205-827Leader Allergy D 12Cetirizine HCl, Pseudoephedrine HCl
    41190-176ShopRite Allergy D 12Cetirizine HCl, Pseudoephedrine HCl
    21130-176Signature Care Allergy Relief DCetirizine HCl, Pseudoephedrine HCl
    49738-709smart sense allergy relief dCetirizine HCl, Pseudoephedrine HCl
    49348-851Sunmark All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    36800-176Topcare All Day Allergy DCetirizine HCl, Pseudoephedrine HCl
    11673-555up and up allergy plus congestion relief dCetirizine HCl, Pseudoephedrine HCl
    0363-0929Wal Zyr DCetirizine HCl, Pseudoephedrine HCl
    0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
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