childrens cetirizine hydrochloride

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens 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 51672-2147
Product ID 51672-2147_390d2d99-47af-c154-e063-6294a90ac905
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090182
Listing Expiration 2027-12-31
Marketing Start 2025-03-20

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 516722147
Hyphenated Format 51672-2147

Supplemental Identifiers

RxCUI
1014673
UPC
0351672214784
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 childrens cetirizine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090182 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-2147-1) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-2147-8) / 120 mL in 1 BOTTLE
source: ndc

Packages (2)

51672-2147-1 1 BOTTLE in 1 CARTON (51672-2147-1) / 240 mL in 1 BOTTLE 51672-2147-8 1 BOTTLE in 1 CARTON (51672-2147-8) / 120 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Childrens Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "390d2d99-47af-c154-e063-6294a90ac905", "openfda": {"upc": ["0351672214784"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["30cbaa91-2216-efd2-e063-6294a90aaaed"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2147-1)  / 240 mL in 1 BOTTLE", "package_ndc": "51672-2147-1", "marketing_start_date": "20250320"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2147-8)  / 120 mL in 1 BOTTLE", "package_ndc": "51672-2147-8", "marketing_start_date": "20250320"}], "brand_name": "Childrens Cetirizine Hydrochloride", "product_id": "51672-2147_390d2d99-47af-c154-e063-6294a90ac905", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51672-2147", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090182", "marketing_category": "ANDA", "marketing_start_date": "20250320", "listing_expiration_date": "20271231"}