Lofena (diclofenac potassium) NDC 15370-180

NDC codes

FDA NDC Directory

Product NDC (as listed)15370-180Labeler and product segments. Claims need a package NDC.

Product NDC at billing width15370-0180Add 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
15370-180-10	15370018010	1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10)Marketed from Oct 25, 2021
15370-180-60	15370018060	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60)Marketed from Oct 25, 2021

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): Lofena
Generic name (nonproprietary): diclofenac potassium
Active ingredients: Diclofenac potassium — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Carwin Pharmaceutical Associates, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076561
Marketing start: Oct 25, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 15370-180_2a1bac02-dabb-4afe-a378-bc4451dcb0ccSPL ID 2a1bac02-dabb-4afe-a378-bc4451dcb0ccSPL set ID 49bd64cc-5edb-44f2-8e24-1249f6a76663RxCUI 857702, 2584350UNII L4D5UA6CB4UPC 0315370180604
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

N415370018010 followed by a unit qualifier and the quantity

Package 15370-0180-10. 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 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of LOFENA ™ ( diclofenac potassium tablets, USP) and other treatment options before deciding to use LOFENA. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). LOFENA is indicated: For treatment of primary dysmenorrhea For relief of mild to moderate pain For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076561

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

FDA NDC Directory listings under ANDA 076561
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Potassium	Diclofenac potassium 25 mg/1	Tablet, Film coatedOral	Carwin Pharmaceutical Associates, LLC	15370-185
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-443
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Amici Pharma Inc.	69292-550
Diclofenac Potassium	Diclofenac potassium 25 mg/1	Tablet, Film coatedOral	Amici Pharma Inc.	69292-548