allergy relief

Generic: cetirizine hydrochloride

Labeler: prodose, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief
Generic Name cetirizine hydrochloride
Labeler prodose, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Prodose, Inc

Identifiers & Regulatory

Product NDC 68210-4159
Product ID 68210-4159_4949097a-aedb-eb3c-e063-6294a90a1192
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077829
Listing Expiration 2027-12-31
Marketing Start 2021-04-28

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 682104159
Hyphenated Format 68210-4159

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

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 allergy relief (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA077829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68210-4159-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

68210-4159-1 1 BLISTER PACK in 1 CARTON (68210-4159-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4949097a-aedb-eb3c-e063-6294a90a1192", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["e0e5f482-0282-410c-8c40-0a33ca4ea23a"], "manufacturer_name": ["Prodose, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68210-4159-1)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68210-4159-1", "marketing_start_date": "20210526"}], "brand_name": "Allergy Relief", "product_id": "68210-4159_4949097a-aedb-eb3c-e063-6294a90a1192", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68210-4159", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Prodose, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy Relief", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077829", "marketing_category": "ANDA", "marketing_start_date": "20210428", "listing_expiration_date": "20271231"}