NDC 42571-133

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0133Add 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
42571-133-29	42571013329	60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 1, 2021
42571-133-30	42571013330	30 TABLET in 1 BOTTLE (42571-133-30)Marketed from Sep 1, 2021
42571-133-60	42571013360	60 TABLET in 1 BOTTLE (42571-133-60)Marketed from Sep 1, 2021
42571-133-90	42571013390	90 TABLET in 1 BOTTLE (42571-133-90)Marketed from Sep 1, 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 DICLOFENAC-SODIUM-MISOPROSTOLSuffix: DICLOFENAC-SODIUM-MISOPROSTOL
Generic name (nonproprietary): diclofenac sodium/misoprostol
Active ingredients: Diclofenac sodium — 50 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Micro Labs Limited
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 42571-133_3afc5367-562f-b4a0-e063-6294a90a2560SPL ID 3afc5367-562f-b4a0-e063-6294a90a2560SPL set ID c61df58d-d6bb-4d3e-9ef8-60caa7d4e762RxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0342571133603, 0342571134600
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

N442571013329 followed by a unit qualifier and the quantity

Package 42571-0133-29. 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 28, 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 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-MISOPROSTOLdiclofenac sodium/misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	TabletOral	Bryant Ranch Prepack	71335-2603

Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL NDC 42571-133