cetirizine hcl

Generic: cetirizine hcl

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hcl
Generic Name cetirizine hcl
Labeler amerisource bergen
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-613
Product ID 46122-613_df610219-ee3e-1e7e-e053-2995a90a94a3
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022429
Listing Expiration 2026-12-31
Marketing Start 2019-06-18

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 46122613
Hyphenated Format 46122-613

Supplemental Identifiers

RxCUI
1014675
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 hcl (source: ndc)
Generic Name cetirizine hcl (source: ndc)
Application Number NDA022429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (46122-613-63) / 25 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

46122-613-63 1 BOTTLE, PLASTIC in 1 CARTON (46122-613-63) / 25 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df610219-ee3e-1e7e-e053-2995a90a94a3", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014675"], "spl_set_id": ["75f2649d-005e-4f16-a7c3-ae966f3a7a00"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (46122-613-63)  / 25 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "46122-613-63", "marketing_start_date": "20190618"}], "brand_name": "Cetirizine HCl", "product_id": "46122-613_df610219-ee3e-1e7e-e053-2995a90a94a3", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "46122-613", "generic_name": "Cetirizine HCl", "labeler_name": "AMERISOURCE BERGEN", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine HCl", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA022429", "marketing_category": "NDA", "marketing_start_date": "20190618", "listing_expiration_date": "20261231"}