ibuprofen

Generic: ibuprofen

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-969
Product ID 71610-969_4522d040-4cd1-6234-e063-6394a90ad9b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075682
Listing Expiration 2026-12-31
Marketing Start 2025-09-26

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 71610969
Hyphenated Format 71610-969

Supplemental Identifiers

RxCUI
197805
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 ANDA075682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-969-60)
  • 180 TABLET in 1 BOTTLE (71610-969-80)
  • 270 TABLET in 1 BOTTLE (71610-969-92)
source: ndc

Packages (3)

71610-969-60 90 TABLET in 1 BOTTLE (71610-969-60) 71610-969-80 180 TABLET in 1 BOTTLE (71610-969-80) 71610-969-92 270 TABLET in 1 BOTTLE (71610-969-92)

Ingredients (1)

ibuprofen (400 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": "4522d040-4cd1-6234-e063-6394a90ad9b9", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805"], "spl_set_id": ["4522cb9e-4999-c455-e063-6294a90a294f"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-969-60)", "package_ndc": "71610-969-60", "marketing_start_date": "20251203"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-969-80)", "package_ndc": "71610-969-80", "marketing_start_date": "20251203"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-969-92)", "package_ndc": "71610-969-92", "marketing_start_date": "20251203"}], "brand_name": "Ibuprofen", "product_id": "71610-969_4522d040-4cd1-6234-e063-6394a90ad9b9", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71610-969", "generic_name": "Ibuprofen", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA075682", "marketing_category": "ANDA", "marketing_start_date": "20250926", "listing_expiration_date": "20261231"}