pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 60 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6728
Product ID 0904-6728_17cb79ab-be13-8feb-e063-6394a90ad9af
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046728
Hyphenated Format 0904-6728

Supplemental Identifiers

RxCUI
1049167
UPC
0309046728467 0309046907060
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 M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0904-6728-46)
  • 1 BOTTLE in 1 CARTON (0904-6728-52) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (2)

0904-6728-46 30 TABLET in 1 BOTTLE (0904-6728-46) 0904-6728-52 1 BOTTLE in 1 CARTON (0904-6728-52) / 100 TABLET in 1 BOTTLE

Ingredients (1)

pseudoephedrine hydrochloride (60 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": "17cb79ab-be13-8feb-e063-6394a90ad9af", "openfda": {"upc": ["0309046728467", "0309046907060"], "unii": ["6V9V2RYJ8N"], "rxcui": ["1049167"], "spl_set_id": ["78fc7358-75d1-e94a-e053-2a91aa0ab0f1"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0904-6728-46)", "package_ndc": "0904-6728-46", "marketing_start_date": "20190829"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6728-52)  / 100 TABLET in 1 BOTTLE", "package_ndc": "0904-6728-52", "marketing_start_date": "20190826"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "0904-6728_17cb79ab-be13-8feb-e063-6394a90ad9af", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0904-6728", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190826", "listing_expiration_date": "20261231"}