cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-1964
Product ID 68071-1964_1d4bf188-0fd0-b281-e063-6294a90a6ac3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077829
Listing Expiration 2026-12-31
Marketing Start 2009-10-01

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 680711964
Hyphenated Format 68071-1964

Supplemental Identifiers

RxCUI
1014678
UPC
0368071196498
UNII
64O047KTOA

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 (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
  • 10 TABLET in 1 BOTTLE (68071-1964-1)
  • 30 TABLET in 1 BOTTLE (68071-1964-3)
  • 7 TABLET in 1 BOTTLE (68071-1964-7)
  • 90 TABLET in 1 BOTTLE (68071-1964-9)
source: ndc

Packages (4)

68071-1964-1 10 TABLET in 1 BOTTLE (68071-1964-1) 68071-1964-3 30 TABLET in 1 BOTTLE (68071-1964-3) 68071-1964-7 7 TABLET in 1 BOTTLE (68071-1964-7) 68071-1964-9 90 TABLET in 1 BOTTLE (68071-1964-9)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d4bf188-0fd0-b281-e063-6294a90a6ac3", "openfda": {"upc": ["0368071196498"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["4913192a-7364-3f19-e054-00144ff8d46c"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-1964-1)", "package_ndc": "68071-1964-1", "marketing_start_date": "20170221"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-1964-3)", "package_ndc": "68071-1964-3", "marketing_start_date": "20170221"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE (68071-1964-7)", "package_ndc": "68071-1964-7", "marketing_start_date": "20170221"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-1964-9)", "package_ndc": "68071-1964-9", "marketing_start_date": "20170221"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "68071-1964_1d4bf188-0fd0-b281-e063-6294a90a6ac3", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68071-1964", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077829", "marketing_category": "ANDA", "marketing_start_date": "20091001", "listing_expiration_date": "20261231"}