cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-799
Product ID 16714-799_31542c85-db9e-4225-bd25-d231710595b0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2026-12-31
Marketing Start 2015-08-05

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 16714799
Hyphenated Format 16714-799

Supplemental Identifiers

RxCUI
1014678
UPC
0316714799049
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 cetirizine hydrochloride (allergy) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (16714-799-01)
  • 100 TABLET in 1 BOTTLE (16714-799-02)
  • 300 TABLET in 1 BOTTLE (16714-799-03)
  • 500 TABLET in 1 BOTTLE (16714-799-04)
source: ndc

Packages (4)

16714-799-01 30 TABLET in 1 BOTTLE (16714-799-01) 16714-799-02 100 TABLET in 1 BOTTLE (16714-799-02) 16714-799-03 300 TABLET in 1 BOTTLE (16714-799-03) 16714-799-04 500 TABLET in 1 BOTTLE (16714-799-04)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31542c85-db9e-4225-bd25-d231710595b0", "openfda": {"upc": ["0316714799049"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["c9d1e26f-c95a-4991-95fa-9ed6ed484fe2"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (16714-799-01)", "package_ndc": "16714-799-01", "marketing_start_date": "20150805"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (16714-799-02)", "package_ndc": "16714-799-02", "marketing_start_date": "20150805"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (16714-799-03)", "package_ndc": "16714-799-03", "marketing_start_date": "20150805"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16714-799-04)", "package_ndc": "16714-799-04", "marketing_start_date": "20150805"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "16714-799_31542c85-db9e-4225-bd25-d231710595b0", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "16714-799", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20150805", "listing_expiration_date": "20261231"}