ibuprofen and pseudoephedrine hydrochloride

Generic: ibuprofen and pseudoephedrine hydrochloride

Labeler: rite-aid
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 rite-aid
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Rite-Aid

Identifiers & Regulatory

Product NDC 11822-0084
Product ID 11822-0084_61dd37ef-591d-42c8-9bdc-bd2a6073e63b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074567
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

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 118220084
Hyphenated Format 11822-0084

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
  • 1 BLISTER PACK in 1 CARTON (11822-0084-5) / 20 TABLET, COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (11822-0084-6) / 40 TABLET, COATED in 1 BLISTER PACK
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": "61dd37ef-591d-42c8-9bdc-bd2a6073e63b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299021"], "spl_set_id": ["483c3bb7-529e-4684-80e1-6646b050988e"], "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": ["Rite-Aid"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11822-0084-5)  / 20 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "11822-0084-5", "marketing_start_date": "20180201"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11822-0084-6)  / 40 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "11822-0084-6", "marketing_start_date": "20180201"}], "brand_name": "Ibuprofen and Pseudoephedrine Hydrochloride", "product_id": "11822-0084_61dd37ef-591d-42c8-9bdc-bd2a6073e63b", "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": "11822-0084", "generic_name": "Ibuprofen and Pseudoephedrine Hydrochloride", "labeler_name": "Rite-Aid", "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": "20180201", "listing_expiration_date": "20261231"}