orudis

Generic: ketoprofen

Labeler: allegis pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orudis
Generic Name ketoprofen
Labeler allegis pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ketoprofen 75 mg/1

Manufacturer
Allegis Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 28595-031
Product ID 28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074014
Listing Expiration 2027-12-31
Marketing Start 2026-01-07

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 28595031
Hyphenated Format 28595-031

Supplemental Identifiers

RxCUI
197856 206992
UNII
90Y4QC304K
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 orudis (source: ndc)
Generic Name ketoprofen (source: ndc)
Application Number ANDA074014 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (28595-031-60)
source: ndc

Packages (1)

28595-031-60 60 CAPSULE in 1 BOTTLE (28595-031-60)

Ingredients (1)

ketoprofen (75 mg/1)

Linked Drug Pages (1)

Orudis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47d0b2fe-e786-c7a7-e063-6394a90a3b3a", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["90Y4QC304K"], "rxcui": ["197856", "206992"], "spl_set_id": ["47d0b808-7142-c7a9-e063-6394a90a6e0d"], "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": ["Allegis Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (28595-031-60)", "package_ndc": "28595-031-60", "marketing_start_date": "20260107"}], "brand_name": "Orudis", "product_id": "28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3a", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "28595-031", "generic_name": "Ketoprofen", "labeler_name": "Allegis Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orudis", "active_ingredients": [{"name": "KETOPROFEN", "strength": "75 mg/1"}], "application_number": "ANDA074014", "marketing_category": "ANDA", "marketing_start_date": "20260107", "listing_expiration_date": "20271231"}