fexofenadine hydrochloride and pseudoephedrine hydrochloride

Generic: fexofenadine hydrochloride and pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride and pseudoephedrine hydrochloride
Generic Name fexofenadine hydrochloride and pseudoephedrine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-724
Product ID 47335-724_554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090818
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

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 47335724
Hyphenated Format 47335-724

Supplemental Identifiers

RxCUI
997406
UPC
0347335724837
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 hydrochloride and pseudoephedrine hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride and pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA090818 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)
  • 2 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)
  • 4 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83)
  • 1 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (7)

47335-724-64 6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) 47335-724-66 2 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) 47335-724-75 4 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) 47335-724-83 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83) 47335-724-94 1 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 47335-724-95 3 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 47335-724-99 2 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

fexofenadine hydrochloride (60 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8", "openfda": {"upc": ["0347335724837"], "unii": ["2S068B75ZU", "6V9V2RYJ8N"], "rxcui": ["997406"], "spl_set_id": ["8afc0167-17bf-4ccd-91c9-8fb9c4e241c1"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (47335-724-64)  / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)", "package_ndc": "47335-724-64", "marketing_start_date": "20180301"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (47335-724-66)  / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)", "package_ndc": "47335-724-66", "marketing_start_date": "20180301"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (47335-724-75)  / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)", "package_ndc": "47335-724-75", "marketing_start_date": "20180301"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83)", "package_ndc": "47335-724-83", "marketing_start_date": "20180301"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (47335-724-94)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "47335-724-94", "marketing_start_date": "20180301"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (47335-724-95)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "47335-724-95", "marketing_start_date": "20180301"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (47335-724-99)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "47335-724-99", "marketing_start_date": "20180301"}], "brand_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "product_id": "47335-724_554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "47335-724", "generic_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA090818", "marketing_category": "ANDA", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}