ibuprofen

Generic: ibuprofen

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler phoenix rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-2396
Product ID 85509-2396_3b51bdea-0879-d416-e063-6394a90a84b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202413
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

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 855092396
Hyphenated Format 85509-2396

Supplemental Identifiers

RxCUI
197807
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA202413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (85509-2396-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (85509-2396-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (85509-2396-9)
source: ndc

Packages (3)

85509-2396-3 30 TABLET, FILM COATED in 1 BOTTLE (85509-2396-3) 85509-2396-6 60 TABLET, FILM COATED in 1 BOTTLE (85509-2396-6) 85509-2396-9 90 TABLET, FILM COATED in 1 BOTTLE (85509-2396-9)

Ingredients (1)

ibuprofen (800 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b51bdea-0879-d416-e063-6394a90a84b4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["3b17587e-b609-42a9-e063-6294a90ab1f8"], "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": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (85509-2396-3)", "package_ndc": "85509-2396-3", "marketing_start_date": "20250730"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (85509-2396-6)", "package_ndc": "85509-2396-6", "marketing_start_date": "20250730"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (85509-2396-9)", "package_ndc": "85509-2396-9", "marketing_start_date": "20250730"}], "brand_name": "Ibuprofen", "product_id": "85509-2396_3b51bdea-0879-d416-e063-6394a90a84b4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "85509-2396", "generic_name": "Ibuprofen", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA202413", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}