pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: cardinal health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler cardinal health
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Cardinal Health

Identifiers & Regulatory

Product NDC 70000-0164
Product ID 70000-0164_2729ed53-f924-47da-b2e8-31fe5851ce90
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2017-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000164
Hyphenated Format 70000-0164

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
  • 10 TABLET, EXTENDED RELEASE in 1 CARTON (70000-0164-1)
source: ndc

Packages (1)

70000-0164-1 10 TABLET, EXTENDED RELEASE in 1 CARTON (70000-0164-1)

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": "2729ed53-f924-47da-b2e8-31fe5851ce90", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["b8ff40d6-d44c-444e-975f-5fd481578332"], "manufacturer_name": ["Cardinal Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, EXTENDED RELEASE in 1 CARTON (70000-0164-1)", "package_ndc": "70000-0164-1", "marketing_start_date": "20170215"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "70000-0164_2729ed53-f924-47da-b2e8-31fe5851ce90", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "70000-0164", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Cardinal Health", "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": "20170215", "listing_expiration_date": "20261231"}