ibuprofen

Generic: ibuprofen

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0537
Product ID 80425-0537_3b9fdc58-687a-4e47-e063-6294a90a0189
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2025-08-05

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 804250537
Hyphenated Format 80425-0537

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
  • 30 TABLET in 1 BOTTLE (80425-0537-1)
  • 60 TABLET in 1 BOTTLE (80425-0537-2)
  • 90 TABLET in 1 BOTTLE (80425-0537-3)
  • 100 TABLET in 1 BOTTLE (80425-0537-4)
  • 120 TABLET in 1 BOTTLE (80425-0537-5)
source: ndc

Packages (5)

80425-0537-1 30 TABLET in 1 BOTTLE (80425-0537-1) 80425-0537-2 60 TABLET in 1 BOTTLE (80425-0537-2) 80425-0537-3 90 TABLET in 1 BOTTLE (80425-0537-3) 80425-0537-4 100 TABLET in 1 BOTTLE (80425-0537-4) 80425-0537-5 120 TABLET in 1 BOTTLE (80425-0537-5)

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": "3b9fdc58-687a-4e47-e063-6294a90a0189", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["3b9fdc48-c071-4e2c-e063-6294a90a679f"], "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": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0537-1)", "package_ndc": "80425-0537-1", "marketing_start_date": "20250805"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0537-2)", "package_ndc": "80425-0537-2", "marketing_start_date": "20250805"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0537-3)", "package_ndc": "80425-0537-3", "marketing_start_date": "20250805"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (80425-0537-4)", "package_ndc": "80425-0537-4", "marketing_start_date": "20250805"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (80425-0537-5)", "package_ndc": "80425-0537-5", "marketing_start_date": "20250805"}], "brand_name": "Ibuprofen", "product_id": "80425-0537_3b9fdc58-687a-4e47-e063-6294a90a0189", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0537", "generic_name": "ibuprofen", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20250805", "listing_expiration_date": "20261231"}