Diclofenac Potassium NDC 42291-042

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-042Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0042Add 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
42291-042-01	42291004201	100 TABLET, FILM COATED in 1 BOTTLE (42291-042-01)Marketed from Sep 11, 2024

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): Diclofenac Potassium
Generic name (nonproprietary): diclofenac potassium
Active ingredients: Diclofenac potassium — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215585
Marketing start: Sep 11, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 42291-042_484c1058-0a5d-1582-e063-6394a90a2985SPL ID 484c1058-0a5d-1582-e063-6394a90a2985SPL set ID 21dc9953-4e6d-50f0-e063-6294a90ac4efRxCUI 855942UNII L4D5UA6CB4UPC 0342291042018
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

N442291004201 followed by a unit qualifier and the quantity

Package 42291-0042-01. 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 Jan 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are 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 215585

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

FDA NDC Directory listings under ANDA 215585
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Ingenus Pharmaceuticals, LLC	50742-279
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3538
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2530
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8697