cetirizine hydrochloride and pseudoephedrine hydrochloride

Generic: cetirizine hydrochloride and pseudoephedrine hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride and pseudoephedrine hydrochloride
Generic Name cetirizine hydrochloride and pseudoephedrine hydrochloride
Labeler aurohealth llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-703
Product ID 58602-703_61a3255b-dd37-4751-9084-6874f799e30e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212409
Listing Expiration 2026-12-31
Marketing Start 2023-03-08

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602703
Hyphenated Format 58602-703

Supplemental Identifiers

RxCUI
1014571
UNII
64O047KTOA 6V9V2RYJ8N

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cetirizine hydrochloride and pseudoephedrine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride and pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA212409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (58602-703-09) / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 12 BLISTER PACK in 1 CARTON (58602-703-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-703-75) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (4)

58602-703-09 12 BLISTER PACK in 1 CARTON (58602-703-09) / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 58602-703-53 12 BLISTER PACK in 1 CARTON (58602-703-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 58602-703-75 2 BLISTER PACK in 1 CARTON (58602-703-75) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 58602-703-76 4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

cetirizine hydrochloride (5 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "61a3255b-dd37-4751-9084-6874f799e30e", "openfda": {"unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571"], "spl_set_id": ["26f2c3c1-a2f2-474a-950a-8cfe07f289fa"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (58602-703-09)  / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-703-09", "marketing_start_date": "20230308"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (58602-703-53)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-703-53", "marketing_start_date": "20230308"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-703-75)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-703-75", "marketing_start_date": "20230308"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-703-76)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-703-76", "marketing_start_date": "20230308"}], "brand_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride", "product_id": "58602-703_61a3255b-dd37-4751-9084-6874f799e30e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "58602-703", "generic_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA212409", "marketing_category": "ANDA", "marketing_start_date": "20230308", "listing_expiration_date": "20261231"}