pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: safeway inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler safeway inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Safeway Inc.

Identifiers & Regulatory

Product NDC 21130-204
Product ID 21130-204_22744b1f-71f8-4db8-b2d5-1da1ea2a452a
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 21130204
Hyphenated Format 21130-204

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 (21130-204-21)
  • 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-69)
source: ndc

Packages (2)

21130-204-21 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-21) 21130-204-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-69)

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": "22744b1f-71f8-4db8-b2d5-1da1ea2a452a", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["01a5d9dd-f123-443b-b968-412c0aadaaa2"], "manufacturer_name": ["Safeway Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-21)", "package_ndc": "21130-204-21", "marketing_start_date": "20060428"}, {"sample": false, "description": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-69)", "package_ndc": "21130-204-69", "marketing_start_date": "20060428"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "21130-204_22744b1f-71f8-4db8-b2d5-1da1ea2a452a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "21130-204", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Safeway Inc.", "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"}