ibuprofen

Generic: ibuprofen

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-564
Product ID 72189-564_410c415a-9f59-049c-e063-6294a90a0012
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213794
Listing Expiration 2026-12-31
Marketing Start 2024-06-27

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 72189564
Hyphenated Format 72189-564

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 ANDA213794 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-564-30)
  • 60 TABLET in 1 BOTTLE (72189-564-60)
source: ndc

Packages (2)

72189-564-30 30 TABLET in 1 BOTTLE (72189-564-30) 72189-564-60 60 TABLET in 1 BOTTLE (72189-564-60)

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": "410c415a-9f59-049c-e063-6294a90a0012", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805"], "spl_set_id": ["1be33b4f-4987-580f-e063-6294a90a3103"], "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": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-564-30)", "package_ndc": "72189-564-30", "marketing_start_date": "20240627"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-564-60)", "package_ndc": "72189-564-60", "marketing_start_date": "20240627"}], "brand_name": "Ibuprofen", "product_id": "72189-564_410c415a-9f59-049c-e063-6294a90a0012", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72189-564", "generic_name": "Ibuprofen", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA213794", "marketing_category": "ANDA", "marketing_start_date": "20240627", "listing_expiration_date": "20261231"}