pentrexcilina day time

Generic: cetirizine hydrochloride

Labeler: opmx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentrexcilina day time
Generic Name cetirizine hydrochloride
Labeler opmx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-137
Product ID 69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2024-11-15

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 69729137
Hyphenated Format 69729-137

Supplemental Identifiers

RxCUI
1014678
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 pentrexcilina day time (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE (69729-137-14)
source: ndc

Packages (1)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "26f56cb7-be59-a0c2-e063-6294a90a15fa", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["26f56cb7-be58-a0c2-e063-6294a90a15fa"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE (69729-137-14)", "package_ndc": "69729-137-14", "marketing_start_date": "20241115"}], "brand_name": "Pentrexcilina Day time", "product_id": "69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69729-137", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pentrexcilina Day time", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20241115", "listing_expiration_date": "20261231"}