Ketoprofen NDC 0378-8200

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8200Add 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
0378-8200-01	00378820001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)Marketed from Sep 4, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Ketoprofen
Generic name (nonproprietary): ketoprofen
Active ingredients: Ketoprofen — 200 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075679
Marketing start: Sep 4, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 0378-8200_2dad8626-e0dd-46ad-9e75-069c6e82fc20SPL ID 2dad8626-e0dd-46ad-9e75-069c6e82fc20SPL set ID 198a4140-f4c0-4478-9157-ee1d68d0bb96RxCUI 359697UNII 90Y4QC304KUPC 0303788200014
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

N400378820001 followed by a unit qualifier and the quantity

Package 00378-8200-01. 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 Jul 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketoprofen extended-release capsules before deciding to use ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)