ibuprofen

Generic: ibuprofen

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler padagis israel pharmaceuticals ltd
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-952
Product ID 45802-952_155cb0b6-81cf-4187-a508-d22b47496707
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076925
Listing Expiration 2026-12-31
Marketing Start 2004-12-08

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 45802952
Hyphenated Format 45802-952

Supplemental Identifiers

RxCUI
197803
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 ANDA076925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-952-26) / 120 mL in 1 BOTTLE
  • 473 mL in 1 BOTTLE (45802-952-43)
source: ndc

Packages (2)

45802-952-26 1 BOTTLE in 1 CARTON (45802-952-26) / 120 mL in 1 BOTTLE 45802-952-43 473 mL in 1 BOTTLE (45802-952-43)

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": "155cb0b6-81cf-4187-a508-d22b47496707", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["998f2fcf-0b40-4304-929f-7f2fa42f66d0"], "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": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-952-26)  / 120 mL in 1 BOTTLE", "package_ndc": "45802-952-26", "marketing_start_date": "20041228"}, {"sample": false, "description": "473 mL in 1 BOTTLE (45802-952-43)", "package_ndc": "45802-952-43", "marketing_start_date": "20041208"}], "brand_name": "Ibuprofen", "product_id": "45802-952_155cb0b6-81cf-4187-a508-d22b47496707", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "45802-952", "generic_name": "Ibuprofen", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA076925", "marketing_category": "ANDA", "marketing_start_date": "20041208", "listing_expiration_date": "20261231"}