ibuprofen

Generic: ibuprofen

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-563
Product ID 68645-563_4c4a254e-39fd-1e60-e063-6294a90a2703
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091625
Listing Expiration 2027-12-31
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 68645563
Hyphenated Format 68645-563

Supplemental Identifiers

RxCUI
197806 197807
UPC
0368645562599 0368645563541
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (68645-563-54)
source: ndc

Packages (1)

68645-563-54 30 TABLET, FILM COATED in 1 BOTTLE (68645-563-54)

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": "4c4a254e-39fd-1e60-e063-6294a90a2703", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368645562599", "0368645563541"], "unii": ["WK2XYI10QM"], "rxcui": ["197806", "197807"], "spl_set_id": ["5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a"], "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": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68645-563-54)", "package_ndc": "68645-563-54", "marketing_start_date": "20151221"}], "brand_name": "Ibuprofen", "product_id": "68645-563_4c4a254e-39fd-1e60-e063-6294a90a2703", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68645-563", "generic_name": "Ibuprofen", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "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": "20271231"}