fexofenadine hcl and pseudoephedrine hcl

Generic: fexofenadine hcl and pseudoephedrine hcl

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

Drug Facts

Product Profile

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

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

Manufacturer
Dr.Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-892
Product ID 43598-892_4eb8619f-5163-2d01-d21d-dec85bc67ab6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079043
Marketing Start 2022-05-17
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 43598892
Hyphenated Format 43598-892

Supplemental Identifiers

RxCUI
997415
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
  • 3 BLISTER PACK in 1 CARTON (43598-892-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (43598-892-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

43598-892-29 3 BLISTER PACK in 1 CARTON (43598-892-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 43598-892-35 2 BLISTER PACK in 1 CARTON (43598-892-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Fexofenadine HCl and Pseudoephedrine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4eb8619f-5163-2d01-d21d-dec85bc67ab6", "openfda": {"unii": ["2S068B75ZU", "6V9V2RYJ8N"], "rxcui": ["997415"], "spl_set_id": ["d4e66d84-5ce8-36a1-7a99-2a2a0f38ce19"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (43598-892-29)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-892-29", "marketing_end_date": "20260730", "marketing_start_date": "20220517"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (43598-892-35)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-892-35", "marketing_end_date": "20260831", "marketing_start_date": "20220517"}], "brand_name": "Fexofenadine HCl and Pseudoephedrine HCl", "product_id": "43598-892_4eb8619f-5163-2d01-d21d-dec85bc67ab6", "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": "43598-892", "generic_name": "Fexofenadine HCl and Pseudoephedrine HCl", "labeler_name": "Dr.Reddy's Laboratories 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": "20220517"}