sinus and nasal decongestant

Generic: pseudoephedrine hydrochloride

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sinus and nasal decongestant
Generic Name pseudoephedrine hydrochloride
Labeler cvs woonsocket prescription center, incorporated
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-616
Product ID 51316-616_00329fc8-144a-4254-8482-87adab8d9685
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075153
Listing Expiration 2027-12-31
Marketing Start 2026-01-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316616
Hyphenated Format 51316-616

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 sinus and nasal decongestant (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
  • 10 BLISTER PACK in 1 CARTON (51316-616-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (51316-616-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

51316-616-52 10 BLISTER PACK in 1 CARTON (51316-616-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 51316-616-60 20 BLISTER PACK in 1 CARTON (51316-616-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

sinus and nasal decongestant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00329fc8-144a-4254-8482-87adab8d9685", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["e39daa3c-1901-4966-b85e-ab76d7bd1216"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (51316-616-52)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-616-52", "marketing_start_date": "20260120"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (51316-616-60)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-616-60", "marketing_start_date": "20260128"}], "brand_name": "sinus and nasal decongestant", "product_id": "51316-616_00329fc8-144a-4254-8482-87adab8d9685", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "51316-616", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "sinus and nasal decongestant", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075153", "marketing_category": "ANDA", "marketing_start_date": "20260120", "listing_expiration_date": "20271231"}