pseudoephedrine hcl

Generic: pseudoephedrine hcl

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hcl
Generic Name pseudoephedrine hcl
Labeler aurohealth llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-804
Product ID 58602-804_5f73d533-1e3b-4e36-8bea-6076b9d0a9b5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209008
Listing Expiration 2026-12-31
Marketing Start 2017-06-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602804
Hyphenated Format 58602-804

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 hcl (source: ndc)
Generic Name pseudoephedrine hcl (source: ndc)
Application Number ANDA209008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (58602-804-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (58602-804-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

58602-804-67 2 BLISTER PACK in 1 CARTON (58602-804-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-804-83 1 BLISTER PACK in 1 CARTON (58602-804-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Pseudoephedrine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5f73d533-1e3b-4e36-8bea-6076b9d0a9b5", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["1056d9da-8a3f-4b7a-878e-7f8d45d298cd"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-804-67)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-804-67", "marketing_start_date": "20170609"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-804-83)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-804-83", "marketing_start_date": "20170609"}], "brand_name": "Pseudoephedrine HCl", "product_id": "58602-804_5f73d533-1e3b-4e36-8bea-6076b9d0a9b5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "58602-804", "generic_name": "Pseudoephedrine HCl", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pseudoephedrine HCl", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA209008", "marketing_category": "ANDA", "marketing_start_date": "20170609", "listing_expiration_date": "20261231"}