cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: strategic sourcing services llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler strategic sourcing services llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
STRATEGIC SOURCING SERVICES LLC

Identifiers & Regulatory

Product NDC 70677-1236
Product ID 70677-1236_3996d9c8-9a1e-e9ca-e063-6294a90a4e8c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090182
Listing Expiration 2026-12-31
Marketing Start 2024-02-02

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 706771236
Hyphenated Format 70677-1236

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 ANDA090182 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70677-1236-1) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

70677-1236-1 1 BOTTLE in 1 CARTON (70677-1236-1) / 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": "3996d9c8-9a1e-e9ca-e063-6294a90a4e8c", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["601c2846-30e7-40f1-96b4-64fbed719c0b"], "manufacturer_name": ["STRATEGIC SOURCING SERVICES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1236-1)  / 120 mL in 1 BOTTLE", "package_ndc": "70677-1236-1", "marketing_start_date": "20240202"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "70677-1236_3996d9c8-9a1e-e9ca-e063-6294a90a4e8c", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70677-1236", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "STRATEGIC SOURCING SERVICES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090182", "marketing_category": "ANDA", "marketing_start_date": "20240202", "listing_expiration_date": "20261231"}