cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4070
Product ID 51672-4070_3b528d29-2957-8382-e063-6294a90aa8a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076601
Listing Expiration 2026-12-31
Marketing Start 2014-05-01

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 516724070
Hyphenated Format 51672-4070

Supplemental Identifiers

RxCUI
1014673
UPC
0351672407087
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 ANDA076601 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-4070-8) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-4070-8 1 BOTTLE in 1 CARTON (51672-4070-8) / 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": "3b528d29-2957-8382-e063-6294a90aa8a7", "openfda": {"upc": ["0351672407087"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["6d81446e-f713-4ca4-af38-3d31cf618873"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-4070-8)  / 120 mL in 1 BOTTLE", "package_ndc": "51672-4070-8", "marketing_start_date": "20140501"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "51672-4070_3b528d29-2957-8382-e063-6294a90aa8a7", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51672-4070", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA076601", "marketing_category": "ANDA", "marketing_start_date": "20140501", "listing_expiration_date": "20261231"}