sudafed sinus congestion 12 hour

Generic: pseudoephedrine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sudafed sinus congestion 12 hour
Generic Name pseudoephedrine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4629
Product ID 50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84
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 500904629
Hyphenated Format 50090-4629

Supplemental Identifiers

RxCUI
1049154 1049668
UNII
6V9V2RYJ8N

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 (50090-4629-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

50090-4629-0 1 BLISTER PACK in 1 CARTON (50090-4629-0) / 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": "51527d7c-26f4-4538-928e-f3ac2bba4f84", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154", "1049668"], "spl_set_id": ["0e4717a1-914b-466d-8bf0-d37ebc32fdb3"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50090-4629-0)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50090-4629-0", "marketing_start_date": "20191021"}], "brand_name": "Sudafed Sinus Congestion 12 Hour", "product_id": "50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50090-4629", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "A-S Medication Solutions", "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"}