ibuprofen

Generic: ibuprofen

Labeler: geritrex llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler geritrex llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Geritrex LLC

Identifiers & Regulatory

Product NDC 54162-941
Product ID 54162-941_f6080edf-c278-4721-8335-4c299adf0c9e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075010
Listing Expiration 2026-12-31
Marketing Start 2018-10-15

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 54162941
Hyphenated Format 54162-941

Supplemental Identifiers

RxCUI
310965
UPC
0354162941009 0354162941900
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

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 ANDA075010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-00)
  • 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-90)
source: ndc

Packages (2)

54162-941-00 100 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-00) 54162-941-90 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-90)

Ingredients (1)

ibuprofen (200 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": "f6080edf-c278-4721-8335-4c299adf0c9e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0354162941009", "0354162941900"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["ca9498ec-755d-4a09-9504-210dd48d6fed"], "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": ["Geritrex LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-00)", "package_ndc": "54162-941-00", "marketing_start_date": "20181015"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-90)", "package_ndc": "54162-941-90", "marketing_start_date": "20181015"}], "brand_name": "Ibuprofen", "product_id": "54162-941_f6080edf-c278-4721-8335-4c299adf0c9e", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "54162-941", "generic_name": "Ibuprofen", "labeler_name": "Geritrex LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA075010", "marketing_category": "ANDA", "marketing_start_date": "20181015", "listing_expiration_date": "20261231"}