ibuprofen and pseudoephedrine hcl (46122-609)

Drug Facts

Product Profile

Brand Name ibuprofen and pseudoephedrine hcl

Generic Name ibuprofen and pseudoephedrine hcl

Labeler amerisource bergen

Dosage Form CAPSULE, LIQUID FILLED

Routes

ORAL

Active Ingredients

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

Manufacturer

Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-609

Product ID 46122-609_7569aff6-da0d-46b9-b7c4-bf2766827013

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209235

Listing Expiration 2026-12-31

Marketing Start 2017-12-01

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 46122609

Hyphenated Format 46122-609

Supplemental Identifiers

RxCUI

1299018

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 hcl (source: ndc)

Generic Name ibuprofen and pseudoephedrine hcl (source: ndc)

Application Number ANDA209235 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
30 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (46122-609-58) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

source: ndc

Packages (1)

46122-609-58 4 BLISTER PACK in 1 CARTON (46122-609-58) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Ibuprofen and Pseudoephedrine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "7569aff6-da0d-46b9-b7c4-bf2766827013", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299018"], "spl_set_id": ["8d397f4f-ac5e-426d-a26b-ee064b6e5028"], "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": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (46122-609-58)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "46122-609-58", "marketing_start_date": "20171201"}], "brand_name": "Ibuprofen and Pseudoephedrine HCl", "product_id": "46122-609_7569aff6-da0d-46b9-b7c4-bf2766827013", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "46122-609", "generic_name": "Ibuprofen and Pseudoephedrine HCl", "labeler_name": "Amerisource Bergen", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen and Pseudoephedrine HCl", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA209235", "marketing_category": "ANDA", "marketing_start_date": "20171201", "listing_expiration_date": "20261231"}