Diclofenac Sodium Misoprostol NDC 71205-865

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-865Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0865Add 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
71205-865-00	71205086500	100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-00)Marketed from Mar 7, 2022
71205-865-30	71205086530	30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-30)Marketed from Mar 7, 2022
71205-865-55	71205086555	500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-55)Marketed from Mar 7, 2022
71205-865-60	71205086560	60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-60)Marketed from Mar 7, 2022
71205-865-64	71205086564	240 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-64)Marketed from Mar 7, 2022
71205-865-72	71205086572	120 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-72)Marketed from Mar 7, 2022
71205-865-90	71205086590	90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-90)Marketed from Mar 7, 2022

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 — 50 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205143
Marketing start: Jul 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Synthetic (Chemical structure)
Identifiers: Product ID 71205-865_47a851b9-3e7f-4271-a2b8-ce836579729bSPL ID 47a851b9-3e7f-4271-a2b8-ce836579729bSPL set ID 33f7db0b-f049-4d2e-abf5-4db97222e175RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0371205866303, 0371205865306
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

N471205086500 followed by a unit qualifier and the quantity

Package 71205-0865-00. 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 Jul 1, 2022. 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 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…

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 75 mg/1; Misoprostol 200 ug/1	Tablet, Delayed releaseOral	Nivagen Pharmaceuticals, Inc.	75834-265
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