ibuprofen and pseudoephedrine hydrochloride (58602-839)

Drug Facts

Product Profile

Brand Name ibuprofen and pseudoephedrine hydrochloride

Generic Name ibuprofen and pseudoephedrine hydrochloride

Labeler aurohealth llc

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

ibuprofen 200 mg/1, pseudoephedrine hydrochloride 30 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-839

Product ID 58602-839_8c55a203-6e1b-4f5b-9788-cde24942b6df

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213565

Listing Expiration 2026-12-31

Marketing Start 2023-03-10

Pharmacologic Class

Established (EPC)

nonsteroidal anti-inflammatory drug [epc]

Mechanism of Action

cyclooxygenase inhibitors [moa]

Chemical Structure

anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602839

Hyphenated Format 58602-839

Supplemental Identifiers

RxCUI

1299021

UNII

WK2XYI10QM 6V9V2RYJ8N

NUI

N0000000160 M0001335 N0000175722

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 ibuprofen and pseudoephedrine hydrochloride (source: ndc)

Generic Name ibuprofen and pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA213565 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
30 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK

source: ndc

Packages (1)

58602-839-13 4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK

Ingredients (2)

ibuprofen (200 mg/1) pseudoephedrine hydrochloride (30 mg/1)

Linked Drug Pages (1)

Ibuprofen and Pseudoephedrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "8c55a203-6e1b-4f5b-9788-cde24942b6df", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299021"], "spl_set_id": ["c01116d3-32f8-41f0-8e31-c4142265ef56"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-839-13)  / 8 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "58602-839-13", "marketing_start_date": "20230310"}], "brand_name": "Ibuprofen and Pseudoephedrine Hydrochloride", "product_id": "58602-839_8c55a203-6e1b-4f5b-9788-cde24942b6df", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "58602-839", "generic_name": "Ibuprofen and Pseudoephedrine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen and Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA213565", "marketing_category": "ANDA", "marketing_start_date": "20230310", "listing_expiration_date": "20261231"}