fexofenadine hcl and pseudoephedrine hcl (51316-018)

Drug Facts

Product Profile

Brand Name fexofenadine hcl and pseudoephedrine hcl

Generic Name fexofenadine hcl and pseudoephedrine hcl

Labeler cvs pharmacy, inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

fexofenadine hydrochloride 180 mg/1, pseudoephedrine hydrochloride 240 mg/1

Manufacturer

CVS Pharmacy, Inc

Identifiers & Regulatory

Product NDC 51316-018

Product ID 51316-018_132629da-7f70-439b-3df7-876d0aeb01ee

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA079043

Marketing Start 2022-11-30

Marketing End 2026-08-31

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316018

Hyphenated Format 51316-018

Supplemental Identifiers

UNII

2S068B75ZU 6V9V2RYJ8N

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 fexofenadine hcl and pseudoephedrine hcl (source: ndc)

Generic Name fexofenadine hcl and pseudoephedrine hcl (source: ndc)

Application Number ANDA079043 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

180 mg/1
240 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (51316-018-10) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3 BLISTER PACK in 1 CARTON (51316-018-15) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

51316-018-10 2 BLISTER PACK in 1 CARTON (51316-018-10) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 51316-018-15 3 BLISTER PACK in 1 CARTON (51316-018-15) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

fexofenadine hydrochloride (180 mg/1) pseudoephedrine hydrochloride (240 mg/1)

Linked Drug Pages (0)

No linked drugs yet.

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "132629da-7f70-439b-3df7-876d0aeb01ee", "openfda": {"unii": ["2S068B75ZU", "6V9V2RYJ8N"], "spl_set_id": ["3a878985-3a0e-1960-db0e-e3b8fd9d5c63"], "manufacturer_name": ["CVS Pharmacy, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-018-10)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-018-10", "marketing_end_date": "20260831", "marketing_start_date": "20221130"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51316-018-15)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-018-15", "marketing_end_date": "20260831", "marketing_start_date": "20221130"}], "brand_name": "Fexofenadine HCl and Pseudoephedrine HCl", "product_id": "51316-018_132629da-7f70-439b-3df7-876d0aeb01ee", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "51316-018", "generic_name": "Fexofenadine HCl and Pseudoephedrine HCl", "labeler_name": "CVS Pharmacy, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine HCl and Pseudoephedrine HCl", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "240 mg/1"}], "application_number": "ANDA079043", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20221130"}