pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler sam's west inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
SAM'S WEST INC

Identifiers & Regulatory

Product NDC 68196-204
Product ID 68196-204_b22ca9ba-71ee-41a5-8395-85eeea13f4a4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2012-02-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68196204
Hyphenated Format 68196-204

Supplemental Identifiers

RxCUI
1049154
UPC
0078742134307
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
  • 2 BLISTER PACK in 1 PACKAGE (68196-204-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

68196-204-20 2 BLISTER PACK in 1 PACKAGE (68196-204-20) / 10 TABLET, FILM COATED 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": "b22ca9ba-71ee-41a5-8395-85eeea13f4a4", "openfda": {"upc": ["0078742134307"], "unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["5a885a10-7751-44f1-b2d9-a918f27604df"], "manufacturer_name": ["SAM'S WEST INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 PACKAGE (68196-204-20)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68196-204-20", "marketing_start_date": "20120207"}], "brand_name": "Pseudoephedrine hydrochloride", "product_id": "68196-204_b22ca9ba-71ee-41a5-8395-85eeea13f4a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "68196-204", "generic_name": "Pseudoephedrine hydrochloride", "labeler_name": "SAM'S WEST INC", "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": "20120207", "listing_expiration_date": "20261231"}