NDC 71335-2603

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2603Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2603Add 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
71335-2603-1	71335260301	20 TABLET in 1 BOTTLE (71335-2603-1)Marketed from Jun 4, 2025
71335-2603-2	71335260302	14 TABLET in 1 BOTTLE (71335-2603-2)Marketed from Jun 4, 2025
71335-2603-3	71335260303	60 TABLET in 1 BOTTLE (71335-2603-3)Marketed from Jun 4, 2025
71335-2603-4	71335260304	30 TABLET in 1 BOTTLE (71335-2603-4)Marketed from Jun 4, 2025
71335-2603-5	71335260305	10 TABLET in 1 BOTTLE (71335-2603-5)Marketed from Jun 4, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 DICLOFENAC-SODIUM-MISOPROSTOLSuffix: DICLOFENAC-SODIUM-MISOPROSTOL
Generic name (nonproprietary): diclofenac sodium/misoprostol
Active ingredients: Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204355
Marketing start: Sep 1, 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 71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456bSPL ID 3ee6724b-9623-434d-ac18-f5d5f55b456bSPL set ID 7225385c-501c-4e90-8948-8617d583108cRxCUI 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

N471335260301 followed by a unit qualifier and the quantity

Package 71335-2603-01. 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 Jun 4, 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 arthr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204355

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

FDA NDC Directory listings under ANDA 204355
Product	Strength	Form · route	Labeler	Product NDC
DICLOENAC SODIUM and MISOPROSTOL DRdicloenac sodium and misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0273
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol	Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1	TabletOral	Micro Labs Limited	42571-133
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	TabletOral	Micro Labs Limited	42571-134
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	TabletOral	Sportpharm LLC	85766-192

Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL NDC 71335-2603