pseudoephedrine hydrochloride

Generic: pseudoephedrine hcl

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hcl
Labeler padagis israel pharmaceuticals ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 30 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-432
Product ID 45802-432_c25dd71c-bfa6-45c6-a4f0-a46919acf185
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2008-10-17

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802432
Hyphenated Format 45802-432

Supplemental Identifiers

RxCUI
1049160
UNII
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 pseudoephedrine hydrochloride (source: ndc)
Generic Name pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (45802-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

45802-432-62 24 BLISTER PACK in 1 CARTON (45802-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (30 mg/1)

Linked Drug Pages (1)

pseudoephedrine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c25dd71c-bfa6-45c6-a4f0-a46919acf185", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049160"], "spl_set_id": ["458594e1-8d99-4de3-8923-2fd8ce2fc406"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (45802-432-62)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "45802-432-62", "marketing_start_date": "20081017"}], "brand_name": "pseudoephedrine hydrochloride", "product_id": "45802-432_c25dd71c-bfa6-45c6-a4f0-a46919acf185", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "45802-432", "generic_name": "Pseudoephedrine HCl", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "pseudoephedrine hydrochloride", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20081017", "listing_expiration_date": "20261231"}