pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler cardinal health 110, llc dba leader
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
CARDINAL HEALTH 110, LLC DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0601
Product ID 70000-0601_604a27bc-af28-4609-a9a2-33c2c60e090a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2022-03-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000601
Hyphenated Format 70000-0601

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
  • 1 BLISTER PACK in 1 CARTON (70000-0601-1) / 20 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0601-1 1 BLISTER PACK in 1 CARTON (70000-0601-1) / 20 TABLET in 1 BLISTER PACK

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": "604a27bc-af28-4609-a9a2-33c2c60e090a", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["a2189d7d-9335-4e96-8f6d-95c583739ac0"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC DBA LEADER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70000-0601-1)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0601-1", "marketing_start_date": "20220309"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "70000-0601_604a27bc-af28-4609-a9a2-33c2c60e090a", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "70000-0601", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "CARDINAL HEALTH 110, LLC DBA LEADER", "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": "20220309", "listing_expiration_date": "20261231"}