cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-402
Product ID 16571-402_76ebe5e7-afda-45c3-bf06-07e37827a07a
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 16571402
Hyphenated Format 16571-402

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 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
  • 100 TABLET in 1 BOTTLE (16571-402-10)
  • 500 TABLET in 1 BOTTLE (16571-402-50)
source: ndc

Packages (2)

16571-402-10 100 TABLET in 1 BOTTLE (16571-402-10) 16571-402-50 500 TABLET in 1 BOTTLE (16571-402-50)

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": "76ebe5e7-afda-45c3-bf06-07e37827a07a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["5481ccb3-b311-4b25-b923-4fe8522ea92b"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-402-10)", "package_ndc": "16571-402-10", "marketing_start_date": "20091001"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-402-50)", "package_ndc": "16571-402-50", "marketing_start_date": "20091001"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "16571-402_76ebe5e7-afda-45c3-bf06-07e37827a07a", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "16571-402", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Rising Pharma Holdings, 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"}