leader 12 hour nasal decongestant

Generic: pseudoephedrine hydrochloride

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader 12 hour nasal decongestant
Generic Name pseudoephedrine hydrochloride
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0475
Product ID 70000-0475_e928de5f-8b3c-4b4b-bde9-8bc98db561d7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075153
Marketing Start 2019-02-11
Marketing End 2027-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000475
Hyphenated Format 70000-0475

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 leader 12 hour 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 (70000-0475-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0475-1 10 BLISTER PACK in 1 CARTON (70000-0475-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

leader 12 hour nasal decongestant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e928de5f-8b3c-4b4b-bde9-8bc98db561d7", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["8b8d374c-592e-44fc-a6cc-9f9e73ef914c"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70000-0475-1)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70000-0475-1", "marketing_end_date": "20270331", "marketing_start_date": "20190211"}], "brand_name": "leader 12 hour nasal decongestant", "product_id": "70000-0475_e928de5f-8b3c-4b4b-bde9-8bc98db561d7", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "70000-0475", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader 12 hour nasal decongestant", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075153", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "20190211"}