ibuprofen

Generic: ibuprofen

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler trifecta pharmaceuticals usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Trifecta Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 69396-145
Product ID 69396-145_2a934860-02a6-a463-e063-6294a90aa446
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207095
Listing Expiration 2026-12-31
Marketing Start 2023-08-08

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 69396145
Hyphenated Format 69396-145

Supplemental Identifiers

RxCUI
310965
UPC
0850058161037
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 ANDA207095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 50 PACKET in 1 BOX (69396-145-01) / 2 TABLET in 1 PACKET
source: ndc

Packages (1)

69396-145-01 50 PACKET in 1 BOX (69396-145-01) / 2 TABLET in 1 PACKET

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": "2a934860-02a6-a463-e063-6294a90aa446", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0850058161037"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["09972806-e064-238d-e063-6394a90a7434"], "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": ["Trifecta Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 BOX (69396-145-01)  / 2 TABLET in 1 PACKET", "package_ndc": "69396-145-01", "marketing_start_date": "20230808"}], "brand_name": "Ibuprofen", "product_id": "69396-145_2a934860-02a6-a463-e063-6294a90aa446", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69396-145", "generic_name": "Ibuprofen", "labeler_name": "Trifecta Pharmaceuticals USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA207095", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}