cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-2106
Product ID 51672-2106_28db7596-f131-dd07-e063-6294a90a5da9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA201546
Listing Expiration 2026-12-31
Marketing Start 2011-05-20

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 516722106
Hyphenated Format 51672-2106

Supplemental Identifiers

RxCUI
1014673
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 ANDA201546 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-2106-1) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-2106-4) / 60 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-2106-8) / 120 mL in 1 BOTTLE
source: ndc

Packages (3)

51672-2106-1 1 BOTTLE in 1 CARTON (51672-2106-1) / 240 mL in 1 BOTTLE 51672-2106-4 1 BOTTLE in 1 CARTON (51672-2106-4) / 60 mL in 1 BOTTLE 51672-2106-8 1 BOTTLE in 1 CARTON (51672-2106-8) / 120 mL in 1 BOTTLE

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": "28db7596-f131-dd07-e063-6294a90a5da9", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["67207357-5f8a-4424-9901-d2717a43cf1b"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2106-1)  / 240 mL in 1 BOTTLE", "package_ndc": "51672-2106-1", "marketing_start_date": "20110520"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2106-4)  / 60 mL in 1 BOTTLE", "package_ndc": "51672-2106-4", "marketing_start_date": "20110520"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2106-8)  / 120 mL in 1 BOTTLE", "package_ndc": "51672-2106-8", "marketing_start_date": "20110520"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "51672-2106_28db7596-f131-dd07-e063-6294a90a5da9", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51672-2106", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA201546", "marketing_category": "ANDA", "marketing_start_date": "20110520", "listing_expiration_date": "20261231"}