Diclofenac sodium and Misoprostol NDC 59762-0028

NDC codes

FDA NDC Directory

Product NDC (as listed)59762-0028Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59762-0028Add 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
59762-0028-1	59762002801	60 TABLET, FILM COATED in 1 BOTTLE (59762-0028-1)Marketed from Nov 1, 2012
59762-0028-2	59762002802	90 TABLET, FILM COATED in 1 BOTTLE (59762-0028-2)Marketed from Nov 1, 2012

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 sodium and Misoprostol
Generic name (nonproprietary): diclofenac sodium and misoprostol
Active ingredients: Diclofenac sodium — 50 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020607
Marketing start: Nov 1, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Synthetic (Chemical structure)
Identifiers: Product ID 59762-0028_354b9b31-a5f4-4f05-b476-2759945ed43eSPL ID 354b9b31-a5f4-4f05-b476-2759945ed43eSPL set ID a7701e8c-4e16-4165-8b83-de2c08d5ded3RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0359762002914, 0359762002815
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; Prostaglandin E1 Analog

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

N459762002801 followed by a unit qualifier and the quantity

Package 59762-0028-01. 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 Aug 31, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ] . Diclofenac sodium/misoprostol is a combination of diclofenac sodium, a non‑steroidal anti‑inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID‑ind…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020607

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

FDA NDC Directory listings under NDA 020607
Product	Strength	Form · route	Labeler	Product NDC
Arthrotecdiclofenac sodium and misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Film coatedOral	Pfizer Laboratories Div Pfizer Inc	0025-1421
Diclofenac sodium and Misoprostol DRdiclofenac sodium and misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0272
Diclofenac sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	59762-0029
Arthrotecdiclofenac sodium and misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Film coatedOral	Pfizer Laboratories Div Pfizer Inc	0025-1411