ibuprofen and pseudoephedrine hydrochloride (51660-423)

Drug Facts

Product Profile

Brand Name ibuprofen and pseudoephedrine hydrochloride

Generic Name ibuprofen and pseudoephedrine hydrochloride

Labeler ohm laboratories inc.

Dosage Form TABLET, SUGAR COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Ohm Laboratories Inc.

Identifiers & Regulatory

Product NDC 51660-423

Product ID 51660-423_2f1cab21-cfa7-0b0e-e063-6294a90a9ae6

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 51660423

Hyphenated Format 51660-423

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 (51660-423-21)
40 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-41)

source: ndc

Packages (2)

51660-423-21 20 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-21) 51660-423-41 40 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-41)

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": "2f1cab21-cfa7-0b0e-e063-6294a90a9ae6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299021"], "spl_set_id": ["65ec0f85-7ca3-4adc-b152-a0ae2fd0692f"], "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": ["Ohm Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-21)", "package_ndc": "51660-423-21", "marketing_start_date": "20011013"}, {"sample": false, "description": "40 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-41)", "package_ndc": "51660-423-41", "marketing_start_date": "20011013"}], "brand_name": "Ibuprofen and Pseudoephedrine hydrochloride", "product_id": "51660-423_2f1cab21-cfa7-0b0e-e063-6294a90a9ae6", "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": "51660-423", "generic_name": "ibuprofen and pseudoephedrine hydrochloride", "labeler_name": "Ohm Laboratories 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"}