pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler walgreen company
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-0204
Product ID 0363-0204_d03cb6bb-f193-4cc7-807f-209cdea81efc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2006-04-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03630204
Hyphenated Format 0363-0204

Supplemental Identifiers

RxCUI
1049154
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 hydrochloride (source: ndc)
Application Number ANDA077442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20)
  • 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69)
source: ndc

Packages (2)

0363-0204-20 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20) 0363-0204-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69)

Ingredients (1)

pseudoephedrine hydrochloride (120 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": "d03cb6bb-f193-4cc7-807f-209cdea81efc", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["e33d6ca8-7b3c-42ad-85d3-3302a949501e"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20)", "package_ndc": "0363-0204-20", "marketing_start_date": "20190116"}, {"sample": false, "description": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69)", "package_ndc": "0363-0204-69", "marketing_start_date": "20060428"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "0363-0204_d03cb6bb-f193-4cc7-807f-209cdea81efc", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0363-0204", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA077442", "marketing_category": "ANDA", "marketing_start_date": "20060428", "listing_expiration_date": "20261231"}