ibuprofen and pseudoephedrine hydrochloride

Generic: ibuprofen and pseudoephedrine hydrochloride

Labeler: publix super markets inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen and pseudoephedrine hydrochloride
Generic Name ibuprofen and pseudoephedrine hydrochloride
Labeler publix super markets inc
Dosage Form TABLET, SUGAR COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Publix Super Markets Inc

Identifiers & Regulatory

Product NDC 56062-423
Product ID 56062-423_645177a7-1d43-439b-9e23-75d5a7822d98
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074567
Listing Expiration 2026-12-31
Marketing Start 2001-10-13

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 56062423
Hyphenated Format 56062-423

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
  • 20 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-21)
  • 40 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-41)
source: ndc

Packages (2)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "645177a7-1d43-439b-9e23-75d5a7822d98", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299021"], "spl_set_id": ["2b98a62b-bd92-4fb8-ad0f-521cb477b612"], "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": ["Publix Super Markets Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-21)", "package_ndc": "56062-423-21", "marketing_start_date": "20011013"}, {"sample": false, "description": "40 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-41)", "package_ndc": "56062-423-41", "marketing_start_date": "20011013"}], "brand_name": "Ibuprofen and Pseudoephedrine Hydrochloride", "product_id": "56062-423_645177a7-1d43-439b-9e23-75d5a7822d98", "dosage_form": "TABLET, SUGAR 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": "56062-423", "generic_name": "Ibuprofen and Pseudoephedrine Hydrochloride", "labeler_name": "Publix Super Markets Inc", "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": "20011013", "listing_expiration_date": "20261231"}