ibuprofen and pseudoephedrine hcl

Generic: ibuprofen and pseudoephedrine hcl

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen and pseudoephedrine hcl
Generic Name ibuprofen and pseudoephedrine hcl
Labeler aurohealth llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-803
Product ID 58602-803_08c50304-67d6-4733-84e4-5a686afa04f3
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 58602803
Hyphenated Format 58602-803

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
  • 1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
  • 4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
  • 4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79)
  • 2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
source: ndc

Packages (4)

58602-803-03 1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) 58602-803-08 4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) 58602-803-13 4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79) 58602-803-67 2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)

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": "08c50304-67d6-4733-84e4-5a686afa04f3", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299018"], "spl_set_id": ["6adf9292-b4af-4cb4-99f3-dda03734570a"], "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": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-803-03)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)", "package_ndc": "58602-803-03", "marketing_start_date": "20200117"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-803-08)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)", "package_ndc": "58602-803-08", "marketing_start_date": "20171201"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-803-13)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79)", "package_ndc": "58602-803-13", "marketing_start_date": "20171201"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-803-67)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)", "package_ndc": "58602-803-67", "marketing_start_date": "20171201"}], "brand_name": "Ibuprofen and Pseudoephedrine HCl", "product_id": "58602-803_08c50304-67d6-4733-84e4-5a686afa04f3", "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": "58602-803", "generic_name": "Ibuprofen and Pseudoephedrine HCl", "labeler_name": "Aurohealth LLC", "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"}