sudafed sinus congestion 12 hour

Generic: pseudoephedrine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sudafed sinus congestion 12 hour
Generic Name pseudoephedrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-242
Product ID 50580-242_216de8df-46aa-927e-e063-6294a90aa11e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075153
Listing Expiration 2026-12-31
Marketing Start 2019-06-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580242
Hyphenated Format 50580-242

Supplemental Identifiers

RxCUI
1049154 1049668
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 sudafed sinus congestion 12 hour (source: ndc)
Generic Name pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA075153 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50580-242-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-242-02) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 CARTON in 1 PACKAGE (50580-242-03) / 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

50580-242-01 1 BLISTER PACK in 1 CARTON (50580-242-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 50580-242-02 2 BLISTER PACK in 1 CARTON (50580-242-02) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 50580-242-03 3 CARTON in 1 PACKAGE (50580-242-03) / 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Sudafed Sinus Congestion 12 Hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "216de8df-46aa-927e-e063-6294a90aa11e", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154", "1049668"], "spl_set_id": ["d600b5d5-7d95-4ad6-a95b-6d73502743d7"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-242-01)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50580-242-01", "marketing_start_date": "20190617"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-242-02)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50580-242-02", "marketing_start_date": "20190617"}, {"sample": false, "description": "3 CARTON in 1 PACKAGE (50580-242-03)  / 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50580-242-03", "marketing_start_date": "20190617"}], "brand_name": "Sudafed Sinus Congestion 12 Hour", "product_id": "50580-242_216de8df-46aa-927e-e063-6294a90aa11e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50580-242", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sudafed Sinus Congestion 12 Hour", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075153", "marketing_category": "ANDA", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}