ibuprofen and pseudoephedrine hydrochloride (70000-0602)

Drug Facts

Product Profile

Brand Name ibuprofen and pseudoephedrine hydrochloride

Generic Name ibuprofen and pseudoephedrine hydrochloride

Labeler cardinal health 110, llc dba leader

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

CARDINAL HEALTH 110, LLC DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0602

Product ID 70000-0602_b5d6426e-cfcc-40c9-b289-c2365eaf0fbb

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA074567

Listing Expiration 2026-12-31

Marketing Start 2022-05-23

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 700000602

Hyphenated Format 70000-0602

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 ANDA074567 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
30 mg/1

source: ndc

Packaging

40 TABLET in 1 BLISTER PACK (70000-0602-1)

source: ndc

Packages (1)

70000-0602-1 40 TABLET in 1 BLISTER PACK (70000-0602-1)

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": "b5d6426e-cfcc-40c9-b289-c2365eaf0fbb", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299021"], "spl_set_id": ["2cccc119-8eea-4280-9ad9-ec29caf26940"], "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": ["CARDINAL HEALTH 110, LLC DBA LEADER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 TABLET in 1 BLISTER PACK (70000-0602-1)", "package_ndc": "70000-0602-1", "marketing_start_date": "20220523"}], "brand_name": "IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE", "product_id": "70000-0602_b5d6426e-cfcc-40c9-b289-c2365eaf0fbb", "dosage_form": "TABLET", "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": "70000-0602", "generic_name": "IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE", "labeler_name": "CARDINAL HEALTH 110, LLC DBA LEADER", "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": "ANDA074567", "marketing_category": "ANDA", "marketing_start_date": "20220523", "listing_expiration_date": "20261231"}