ibuprofen

Generic: ibuprofen

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler actavis pharma, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-2002
Product ID 0472-2002_2e9a1263-be1c-4fa3-8108-0a634fec2593
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074978
Listing Expiration 2026-12-31
Marketing Start 2018-07-16

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 04722002
Hyphenated Format 0472-2002

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 ANDA074978 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0472-2002-16)
  • 1 BOTTLE in 1 CARTON (0472-2002-94) / 118 mL in 1 BOTTLE
source: ndc

Packages (2)

0472-2002-16 473 mL in 1 BOTTLE (0472-2002-16) 0472-2002-94 1 BOTTLE in 1 CARTON (0472-2002-94) / 118 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": "2e9a1263-be1c-4fa3-8108-0a634fec2593", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["3d156d13-25d8-4cfc-8285-5f7ebf48cf45"], "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": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0472-2002-16)", "package_ndc": "0472-2002-16", "marketing_start_date": "20180716"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0472-2002-94)  / 118 mL in 1 BOTTLE", "package_ndc": "0472-2002-94", "marketing_start_date": "20180814"}], "brand_name": "Ibuprofen", "product_id": "0472-2002_2e9a1263-be1c-4fa3-8108-0a634fec2593", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0472-2002", "generic_name": "Ibuprofen", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074978", "marketing_category": "ANDA", "marketing_start_date": "20180716", "listing_expiration_date": "20261231"}