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 SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-358
Product ID 57237-358_836319e1-8b7b-46a4-8303-5d241c6dcb98
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091327
Listing Expiration 2026-12-31
Marketing Start 2025-11-11

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 57237358
Hyphenated Format 57237-358

Supplemental Identifiers

RxCUI
1014673
UPC
0357237358245
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 ANDA091327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (57237-358-12)
  • 240 mL in 1 BOTTLE, PLASTIC (57237-358-24)
source: ndc

Packages (2)

57237-358-12 120 mL in 1 BOTTLE, PLASTIC (57237-358-12) 57237-358-24 240 mL in 1 BOTTLE, PLASTIC (57237-358-24)

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

CETIRIZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "836319e1-8b7b-46a4-8303-5d241c6dcb98", "openfda": {"upc": ["0357237358245"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["06cdcbe0-6c7c-4b91-8158-08ef2e0876dc"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (57237-358-12)", "package_ndc": "57237-358-12", "marketing_start_date": "20251111"}, {"sample": false, "description": "240 mL in 1 BOTTLE, PLASTIC (57237-358-24)", "package_ndc": "57237-358-24", "marketing_start_date": "20251111"}], "brand_name": "CETIRIZINE HYDROCHLORIDE", "product_id": "57237-358_836319e1-8b7b-46a4-8303-5d241c6dcb98", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57237-358", "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": "1 mg/mL"}], "application_number": "ANDA091327", "marketing_category": "ANDA", "marketing_start_date": "20251111", "listing_expiration_date": "20261231"}