What is NDC 42291-232?

42291-232 is the product NDC for Diclofenac Sodium and Misoprostol, Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 tablet, delayed release, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Diclofenac sodium, Misoprostol.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diclofenac Sodium and Misoprostol?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diclofenac Sodium and Misoprostol NDC 42291-232

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-232Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0232Add 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
42291-232-60	4229102326042291023260	60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-232-60)Marketed from Sep 26, 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 — 50 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201089
Marketing start: Dec 14, 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 42291-232_4dc7edc1-b426-ac49-e063-6294a90af71bSPL ID 4dc7edc1-b426-ac49-e063-6294a90af71bSPL set ID 3643ab1b-9f8f-b2f4-e02d-950d0a02e587RxCUI 857706, 1359105UNII QTG126297Q, 0E43V0BB57
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

N442291023260 followed by a unit qualifier and the quantity

Package 42291-0232-60. 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 Mar 24, 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 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 (5.2) ]. Diclofenac sodium and misoprostol delayed-release tablets are a combination non-steroidal anti-inflammatory and prostaglandin E 1 analog drug indicated for the treatment of signs and symptoms of osteoarthritis (OA) or rheumatoid arthritis (RA) in patients at high risk of developing …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-232

What is NDC 42291-232?: 42291-232 is the product NDC for Diclofenac Sodium and Misoprostol, Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 tablet, delayed release, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac Sodium and Misoprostol.
What is the active ingredient?: Diclofenac sodium, Misoprostol.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diclofenac Sodium and Misoprostol?: 10 other product NDCs are listed under this name. See all Diclofenac Sodium and Misoprostol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diclofenac Sodium and Misoprostol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-436	65162-0436-0365162-0436-0665162-0436-09+1 more
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-438	65162-0438-0365162-0438-0665162-0438-10
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-1183	71335-1183-0171335-1183-0271335-1183-03+2 more
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-231	68001-0231-06
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-232	68001-0232-06
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	AvKARE	42291-233	42291-0233-60
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Actavis Pharma, Inc.	0591-0397	00591-0397-1900591-0397-60
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Actavis Pharma, Inc.	0591-0398	00591-0398-60
Diclofenac sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	59762-0028	59762-0028-0159762-0028-02
Diclofenac sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	59762-0029	59762-0029-01

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	Actavis Pharma, Inc.	0591-0397
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	AvKARE	42291-233
Diclofenac Sodium and Misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-231
Diclofenac Sodium and Misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-232