cetrizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: apozeal pharmaceuticals inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetrizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler apozeal pharmaceuticals inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
APOZEAL PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 83745-188
Product ID 83745-188_4af0cd5e-46c5-4571-9e04-b8bf16f21b50
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090474
Listing Expiration 2027-12-31
Marketing Start 2025-01-01

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 83745188
Hyphenated Format 83745-188

Supplemental Identifiers

RxCUI
1014673
UPC
0383745188241
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 cetrizine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE
  • 120 mL in 1 BOTTLE, PLASTIC (83745-188-12)
  • 240 mL in 1 BOTTLE, PLASTIC (83745-188-24)
source: ndc

Packages (4)

83745-188-04 1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE 83745-188-08 1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE 83745-188-12 120 mL in 1 BOTTLE, PLASTIC (83745-188-12) 83745-188-24 240 mL in 1 BOTTLE, PLASTIC (83745-188-24)

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Cetrizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4af0cd5e-46c5-4571-9e04-b8bf16f21b50", "openfda": {"upc": ["0383745188241"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["9c0549cf-4c93-45d9-9eac-3948fa45554e"], "manufacturer_name": ["APOZEAL PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83745-188-04)  / 118 mL in 1 BOTTLE", "package_ndc": "83745-188-04", "marketing_start_date": "20260120"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (83745-188-08)  / 237 mL in 1 BOTTLE", "package_ndc": "83745-188-08", "marketing_start_date": "20260120"}, {"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (83745-188-12)", "package_ndc": "83745-188-12", "marketing_start_date": "20260120"}, {"sample": false, "description": "240 mL in 1 BOTTLE, PLASTIC (83745-188-24)", "package_ndc": "83745-188-24", "marketing_start_date": "20260120"}], "brand_name": "Cetrizine Hydrochloride", "product_id": "83745-188_4af0cd5e-46c5-4571-9e04-b8bf16f21b50", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83745-188", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "APOZEAL PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetrizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090474", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20271231"}