ibuprofen

Generic: ibuprofen

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler medline industries, lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Medline industries, LP

Identifiers & Regulatory

Product NDC 53329-674
Product ID 53329-674_02818b70-7259-29dc-e063-6294a90a746f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079174
Listing Expiration 2026-12-31
Marketing Start 2017-09-29

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 53329674
Hyphenated Format 53329-674

Supplemental Identifiers

RxCUI
310965
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 ANDA079174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53329-674-30) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

53329-674-30 1 BOTTLE in 1 CARTON (53329-674-30) / 100 TABLET in 1 BOTTLE

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": "02818b70-7259-29dc-e063-6294a90a746f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["5d2482b4-cd90-4246-85a9-fd1d35315b6c"], "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": ["Medline industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53329-674-30)  / 100 TABLET in 1 BOTTLE", "package_ndc": "53329-674-30", "marketing_start_date": "20170929"}], "brand_name": "Ibuprofen", "product_id": "53329-674_02818b70-7259-29dc-e063-6294a90a746f", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53329-674", "generic_name": "Ibuprofen", "labeler_name": "Medline industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079174", "marketing_category": "ANDA", "marketing_start_date": "20170929", "listing_expiration_date": "20261231"}