Diclofenac Sodium and Misoprostol NDC 65162-438

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-438Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0438Add 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
65162-438-03	65162043803	30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03)Marketed from Dec 1, 2016
65162-438-06	65162043806	60 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-06)Marketed from Dec 1, 2016
65162-438-10	65162043810	100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10)Marketed from Dec 1, 2016

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 Sodium and Misoprostol
Generic name (nonproprietary): diclofenac sodium and misoprostol
Active ingredients: Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203995
Marketing start: Dec 1, 2016
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 65162-438_0426969f-80c3-4157-b42a-ad57d204d011SPL ID 0426969f-80c3-4157-b42a-ad57d204d011SPL set ID afd30051-8f59-474b-9972-962a5a871dfbRxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0365162438062, 0365162436068
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

N465162043803 followed by a unit qualifier and the quantity

Package 65162-0438-03. 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 Apr 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium and misoprostol delayed-release tablets are 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 and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PG E1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203995

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

FDA NDC Directory listings under ANDA 203995
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-436
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-1183