pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

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

pseudoephedrine hydrochloride 240 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-884
Product ID 58602-884_77e4132e-470e-4fb4-bc2f-df2e59061ba9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218854
Listing Expiration 2027-12-31
Marketing Start 2025-12-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602884
Hyphenated Format 58602-884

Supplemental Identifiers

RxCUI
1049670
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 ANDA218854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-884-58) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

58602-884-27 1 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-884-58 2 BLISTER PACK in 1 CARTON (58602-884-58) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (240 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": "77e4132e-470e-4fb4-bc2f-df2e59061ba9", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049670"], "spl_set_id": ["77e4132e-470e-4fb4-bc2f-df2e59061ba9"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-884-27)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-884-27", "marketing_start_date": "20251229"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-884-58)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-884-58", "marketing_start_date": "20251229"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "58602-884_77e4132e-470e-4fb4-bc2f-df2e59061ba9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "58602-884", "generic_name": "pseudoephedrine hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "240 mg/1"}], "application_number": "ANDA218854", "marketing_category": "ANDA", "marketing_start_date": "20251229", "listing_expiration_date": "20271231"}