fexofenadine hcl and pseudoephedrine hci

Generic: fexofenadine hcl and pseudoephedrine hci

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl and pseudoephedrine hci
Generic Name fexofenadine hcl and pseudoephedrine hci
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-447
Product ID 55111-447_2624a9e0-c674-dcc0-472d-888f41fc0436
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076667
Listing Expiration 2026-12-31
Marketing Start 2014-11-18

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 55111447
Hyphenated Format 55111-447

Supplemental Identifiers

RxCUI
997406
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 hci (source: ndc)
Generic Name fexofenadine hcl and pseudoephedrine hci (source: ndc)
Application Number ANDA076667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (55111-447-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)
  • 6 BLISTER PACK in 1 CARTON (55111-447-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)
  • 2 BLISTER PACK in 1 CARTON (55111-447-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)
source: ndc

Packages (3)

55111-447-14 4 BLISTER PACK in 1 CARTON (55111-447-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) 55111-447-31 6 BLISTER PACK in 1 CARTON (55111-447-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) 55111-447-35 2 BLISTER PACK in 1 CARTON (55111-447-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)

Ingredients (2)

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

Linked Drug Pages (1)

Fexofenadine HCl and Pseudoephedrine HCI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2624a9e0-c674-dcc0-472d-888f41fc0436", "openfda": {"unii": ["2S068B75ZU", "6V9V2RYJ8N"], "rxcui": ["997406"], "spl_set_id": ["728632be-7e5c-2d06-4c95-bc8ecc9be2ec"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (55111-447-14)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)", "package_ndc": "55111-447-14", "marketing_start_date": "20141118"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (55111-447-31)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)", "package_ndc": "55111-447-31", "marketing_start_date": "20141118"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (55111-447-35)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07)", "package_ndc": "55111-447-35", "marketing_start_date": "20141118"}], "brand_name": "Fexofenadine HCl and Pseudoephedrine HCI", "product_id": "55111-447_2624a9e0-c674-dcc0-472d-888f41fc0436", "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": "55111-447", "generic_name": "Fexofenadine HCl and Pseudoephedrine HCI", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine HCl and Pseudoephedrine HCI", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076667", "marketing_category": "ANDA", "marketing_start_date": "20141118", "listing_expiration_date": "20261231"}