Diclofenac Sodium and Misoprostol NDC 0591-0397

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-0397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-0397Add 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
0591-0397-19	00591039719	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)Marketed from Nov 1, 2012
0591-0397-60	00591039760	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)Marketed from Nov 1, 2012

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): Diclofenac Sodium and Misoprostol
Generic name (nonproprietary): diclofenac sodium and misoprostol
Active ingredients: Diclofenac sodium — 50 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201089
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 0591-0397_74d02999-d777-4cda-94b9-7b2420a8258cSPL ID 74d02999-d777-4cda-94b9-7b2420a8258cSPL set ID df8b8660-0c24-4848-8bea-c1b935090c66RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0305910397609, 0305910398606
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

N400591039719 followed by a unit qualifier and the quantity

Package 00591-0397-19. 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 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 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthrit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201089

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

FDA NDC Directory listings under ANDA 201089
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	AvKARE	42291-232
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	AvKARE	42291-233
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Actavis Pharma, Inc.	0591-0398
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-232
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-231