ibuprofen

Generic: ibuprofen

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-364
Product ID 72789-364_2bae0294-44aa-33ff-e063-6294a90a8386
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091625
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

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 72789364
Hyphenated Format 72789-364

Supplemental Identifiers

RxCUI
197807
UPC
0372789364100
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 ANDA091625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-06)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-40)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-90)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-93)
source: ndc

Packages (10)

72789-364-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-06) 72789-364-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-10) 72789-364-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-15) 72789-364-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-20) 72789-364-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-21) 72789-364-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-30) 72789-364-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-40) 72789-364-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-60) 72789-364-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-90) 72789-364-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-93)

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": "2bae0294-44aa-33ff-e063-6294a90a8386", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0372789364100"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-06)", "package_ndc": "72789-364-06", "marketing_start_date": "20240315"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-10)", "package_ndc": "72789-364-10", "marketing_start_date": "20231113"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-15)", "package_ndc": "72789-364-15", "marketing_start_date": "20231211"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-20)", "package_ndc": "72789-364-20", "marketing_start_date": "20231211"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-21)", "package_ndc": "72789-364-21", "marketing_start_date": "20240111"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-30)", "package_ndc": "72789-364-30", "marketing_start_date": "20231114"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-40)", "package_ndc": "72789-364-40", "marketing_start_date": "20231115"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-60)", "package_ndc": "72789-364-60", "marketing_start_date": "20231113"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-90)", "package_ndc": "72789-364-90", "marketing_start_date": "20240124"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-93)", "package_ndc": "72789-364-93", "marketing_start_date": "20231212"}], "brand_name": "Ibuprofen", "product_id": "72789-364_2bae0294-44aa-33ff-e063-6294a90a8386", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-364", "generic_name": "Ibuprofen", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA091625", "marketing_category": "ANDA", "marketing_start_date": "20151221", "listing_expiration_date": "20261231"}