NDC 63868-964

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Chain Drug Marketing Association, Inc.. The primary component is Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride.

• Product ID: 63868-964_18f49be0-7363-4791-8e46-ffc2a11e7286
• NDC: 63868-964
• Product Type: Human Otc Drug
• Proprietary Name: Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
• Generic Name: Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090922
• Labeler Name: Chain Drug Marketing Association, Inc.
• Substance Name: CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63868-964-24

4 BLISTER PACK in 1 CARTON (63868-964-24) > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63868-964-73)

• Marketing Start Date: 2016-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63868-964-24 [63868096424]

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA090922
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-03-03
• Inactivation Date: 2020-01-31

NDC 63868-964-73 [63868096473]

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA090922
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-03-03

Drug Details

Active Ingredients

Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: b83d0d38-442c-41ee-88c3-51690edbcd91
• Manufacturer:
  • Chain Drug Marketing Association, Inc.
• UNII:
  • 6V9V2RYJ8N
  • 64O047KTOA
• RxNorm Concept Unique ID - RxCUI:
  • 1014571

NDC Crossover Matching brand name "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride" or generic name "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
45802-147	Cetirizine hydrochloride and Pseudoephedrine hydrochloride	Cetirizine hydrochloride, Pseudoephedrine hydrochloride
45802-721	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine HCl, Pseudoephedrine HCl
50090-1098	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine HCl, Pseudoephedrine HCl
62756-915	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
63187-955	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine HCl, Pseudoephedrine HCl
63868-964	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
68258-8907	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine HCl, Pseudoephedrine HCl
70677-0146	all day allergy-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
49035-982	Allergy relief-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
51660-940	Allergy relief-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
68016-531	Allergy relief-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
69842-994	Allergy Relief-D	Cetirizine hydrochloride and pseudoephedrine hydrochloride
70000-0163	Allergy relief-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
0363-0989	Wal-Zyr D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
50580-728	ZYRTEC-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride