Diclofenac Sodium Misoprostol NDC 75834-265

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-265Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0265Add 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
75834-265-60	75834026560	60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)Marketed from Jul 15, 2021

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 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: Nivagen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205143
Marketing start: Jul 15, 2021
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 75834-265_542fd9dd-a6d3-4432-9e7a-2ca5bce12956SPL ID 542fd9dd-a6d3-4432-9e7a-2ca5bce12956SPL set ID 2acf46ac-8ba8-444d-b421-19d5ad49644cRxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0375834264608, 0375834265605
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

N475834026560 followed by a unit qualifier and the quantity

Package 75834-0265-60. 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 Dec 17, 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 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205143

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

FDA NDC Directory listings under ANDA 205143
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Proficient Rx LP	71205-866
Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Proficient Rx LP	71205-865
Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Nivagen Pharmaceuticals, Inc.	75834-264
Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	72162-2518
Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	72162-2519
Diclofenac Sodium Misoprostoldiclofenac sodium and misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-2441