ibuprofen

Generic: ibuprofen oral

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen oral
Labeler aurobindo pharma limited
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-032
Product ID 59651-032_82801fa0-32ef-4b77-b03f-fde7331293ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209178
Listing Expiration 2026-12-31
Marketing Start 2018-02-16

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 59651032
Hyphenated Format 59651-032

Supplemental Identifiers

RxCUI
197803
UPC
0359651032121
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 oral (source: ndc)
Application Number ANDA209178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-032-12) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (59651-032-47) / 473 mL in 1 BOTTLE
source: ndc

Packages (2)

59651-032-12 1 BOTTLE in 1 CARTON (59651-032-12) / 120 mL in 1 BOTTLE 59651-032-47 1 BOTTLE in 1 CARTON (59651-032-47) / 473 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "82801fa0-32ef-4b77-b03f-fde7331293ae", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0359651032121"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["758eeb45-e599-4c1a-969d-8fa33f27bf14"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-032-12)  / 120 mL in 1 BOTTLE", "package_ndc": "59651-032-12", "marketing_start_date": "20180216"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-032-47)  / 473 mL in 1 BOTTLE", "package_ndc": "59651-032-47", "marketing_start_date": "20180518"}], "brand_name": "Ibuprofen", "product_id": "59651-032_82801fa0-32ef-4b77-b03f-fde7331293ae", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "59651-032", "generic_name": "Ibuprofen Oral", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA209178", "marketing_category": "ANDA", "marketing_start_date": "20180216", "listing_expiration_date": "20261231"}