pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: chain drug consortium, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler chain drug consortium, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Chain Drug Consortium, LLC

Identifiers & Regulatory

Product NDC 68016-204
Product ID 68016-204_f73d7997-407d-4a93-99f5-0f2be115cc51
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2006-04-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016204
Hyphenated Format 68016-204

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, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68016-204-69)
source: ndc

Packages (1)

68016-204-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68016-204-69)

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": "f73d7997-407d-4a93-99f5-0f2be115cc51", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["aec6412a-b62c-44c8-84f5-77f5fa441028"], "manufacturer_name": ["Chain Drug Consortium, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68016-204-69)", "package_ndc": "68016-204-69", "marketing_start_date": "20060428"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "68016-204_f73d7997-407d-4a93-99f5-0f2be115cc51", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "68016-204", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Chain Drug Consortium, LLC", "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": "20060428", "listing_expiration_date": "20261231"}