cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-134
Product ID 16571-134_8ed398ca-3d43-43b4-9597-4457d6943357
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090191
Listing Expiration 2027-12-31
Marketing Start 2024-07-16

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 16571134
Hyphenated Format 16571-134

Supplemental Identifiers

RxCUI
1014673
UPC
0316571134120
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 ANDA090191 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (16571-134-12)
  • 480 mL in 1 BOTTLE, PLASTIC (16571-134-48)
source: ndc

Packages (2)

16571-134-12 120 mL in 1 BOTTLE, PLASTIC (16571-134-12) 16571-134-48 480 mL in 1 BOTTLE, PLASTIC (16571-134-48)

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": "8ed398ca-3d43-43b4-9597-4457d6943357", "openfda": {"upc": ["0316571134120"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["efabbad5-a162-45c8-a896-5af58e5d2d39"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (16571-134-12)", "package_ndc": "16571-134-12", "marketing_start_date": "20240716"}, {"sample": false, "description": "480 mL in 1 BOTTLE, PLASTIC (16571-134-48)", "package_ndc": "16571-134-48", "marketing_start_date": "20240716"}], "brand_name": "CETIRIZINE HYDROCHLORIDE", "product_id": "16571-134_8ed398ca-3d43-43b4-9597-4457d6943357", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "16571-134", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CETIRIZINE HYDROCHLORIDE", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090191", "marketing_category": "ANDA", "marketing_start_date": "20240716", "listing_expiration_date": "20271231"}