ibuprofen

Generic: ibuprofen

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ibuprofen 800 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8710
Product ID 68788-8710_89ae0384-81b4-4573-8ca4-2462aa38e36d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2024-07-05

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 687888710
Hyphenated Format 68788-8710

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 ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8710-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8710-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8710-3)
  • 14 TABLET, FILM COATED in 1 BOTTLE (68788-8710-4)
  • 50 TABLET, FILM COATED in 1 BOTTLE (68788-8710-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8710-6)
  • 21 TABLET, FILM COATED in 1 BOTTLE (68788-8710-7)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68788-8710-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8710-9)
source: ndc

Packages (9)

68788-8710-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8710-1) 68788-8710-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8710-2) 68788-8710-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8710-3) 68788-8710-4 14 TABLET, FILM COATED in 1 BOTTLE (68788-8710-4) 68788-8710-5 50 TABLET, FILM COATED in 1 BOTTLE (68788-8710-5) 68788-8710-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8710-6) 68788-8710-7 21 TABLET, FILM COATED in 1 BOTTLE (68788-8710-7) 68788-8710-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-8710-8) 68788-8710-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8710-9)

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": "89ae0384-81b4-4573-8ca4-2462aa38e36d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["60c731c6-4dc4-490a-8469-0b7e58e563a1"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8710-1)", "package_ndc": "68788-8710-1", "marketing_start_date": "20240705"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8710-2)", "package_ndc": "68788-8710-2", "marketing_start_date": "20240705"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8710-3)", "package_ndc": "68788-8710-3", "marketing_start_date": "20240705"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68788-8710-4)", "package_ndc": "68788-8710-4", "marketing_start_date": "20240705"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (68788-8710-5)", "package_ndc": "68788-8710-5", "marketing_start_date": "20240705"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8710-6)", "package_ndc": "68788-8710-6", "marketing_start_date": "20240705"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (68788-8710-7)", "package_ndc": "68788-8710-7", "marketing_start_date": "20240705"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-8710-8)", "package_ndc": "68788-8710-8", "marketing_start_date": "20240705"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8710-9)", "package_ndc": "68788-8710-9", "marketing_start_date": "20240705"}], "brand_name": "Ibuprofen", "product_id": "68788-8710_89ae0384-81b4-4573-8ca4-2462aa38e36d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-8710", "generic_name": "Ibuprofen", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20240705", "listing_expiration_date": "20261231"}