ibuprofen

Generic: ibuprofen

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-446
Product ID 60687-446_3f29ab46-9311-caa0-e063-6294a90a8f05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078558
Listing Expiration 2026-12-31
Marketing Start 2019-10-01

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 60687446
Hyphenated Format 60687-446

Supplemental Identifiers

RxCUI
197805 197806 197807
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 ANDA078558 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-446-01) / 1 TABLET in 1 BLISTER PACK (60687-446-11)
source: ndc

Packages (1)

60687-446-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-446-01) / 1 TABLET in 1 BLISTER PACK (60687-446-11)

Ingredients (1)

ibuprofen (400 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": "3f29ab46-9311-caa0-e063-6294a90a8f05", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["e080f7da-a506-4c04-a227-c1be77234f01"], "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": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-446-01)  / 1 TABLET in 1 BLISTER PACK (60687-446-11)", "package_ndc": "60687-446-01", "marketing_start_date": "20191001"}], "brand_name": "Ibuprofen", "product_id": "60687-446_3f29ab46-9311-caa0-e063-6294a90a8f05", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60687-446", "generic_name": "Ibuprofen", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA078558", "marketing_category": "ANDA", "marketing_start_date": "20191001", "listing_expiration_date": "20261231"}