Orudis (ketoprofen) NDC 28595-031

NDC codes

FDA NDC Directory

Product NDC (as listed)28595-031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width28595-0031Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
28595-031-60	28595003160	60 CAPSULE in 1 BOTTLE (28595-031-60)Marketed from Jan 7, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Orudis
Generic name (nonproprietary): ketoprofen
Active ingredients: Ketoprofen — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Allegis Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074014
Marketing start: Jan 7, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3aSPL ID 47d0b2fe-e786-c7a7-e063-6394a90a3b3aSPL set ID 47d0b808-7142-c7a9-e063-6394a90a6e0dRxCUI 197856, 206992UNII 90Y4QC304K
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N428595003160 followed by a unit qualifier and the quantity

Package 28595-0031-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ORUDIS capsules USP and other treatment options before deciding to use ORUDIS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). ORUDIS is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ORUDIS is indicated for the management of pain. ORUDIS indicated for treatment of primary dysmenorrhea.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074014

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074014
Product	Strength	Form · route	Labeler	Product NDC
Ketoprofen	Ketoprofen 75 mg/1	CapsuleOral	Marnel Pharmaceuticals, Inc.	0682-0150
Ketoprofen	Ketoprofen 25 mg/1	CapsuleOral	Misemer Pharmaceuticals, Inc.	0276-0504
Ketoprofen	Ketoprofen 50 mg/1	CapsuleOral	Misemer Pharmaceuticals, Inc.	0276-0506
Ketoprofen	Ketoprofen 75 mg/1	CapsuleOral	Misemer Pharmaceuticals, Inc.	0276-0507
Ketoprofen	Ketoprofen 50 mg/1	CapsuleOral	Oncora Pharma, LLC	85477-111