What is NDC 80425-0273?

80425-0273 is the product NDC for DICLOENAC SODIUM and MISOPROSTOL DR, Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

DICLOENAC SODIUM and MISOPROSTOL DR (DICLOENAC SODIUM and MISOPROSTOL).

What is the active ingredient?

Diclofenac sodium, Misoprostol.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for DICLOENAC SODIUM and MISOPROSTOL DR?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

DICLOENAC SODIUM and MISOPROSTOL DR NDC 80425-0273

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0273Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0273Add 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
80425-0273-1	8042502730180425027301	60 TABLET in 1 BOTTLE (80425-0273-1)Marketed from Feb 16, 2023

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): DICLOENAC SODIUM and MISOPROSTOL DRSuffix: DR
Generic name (nonproprietary): dicloenac sodium and misoprostol
Active ingredients: Diclofenac sodium — 75 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204355
Marketing start: Feb 16, 2023
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 80425-0273_12141491-25f0-fbc5-e063-6394a90a1f23SPL ID 12141491-25f0-fbc5-e063-6394a90a1f23SPL set ID f4d8c198-63e1-3109-e053-2995a90acad9RxCUI 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

N480425027301 followed by a unit qualifier and the quantity

Package 80425-0273-01. 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 Feb 23, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage 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)] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0273

What is NDC 80425-0273?: 80425-0273 is the product NDC for DICLOENAC SODIUM and MISOPROSTOL DR, Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: DICLOENAC SODIUM and MISOPROSTOL DR (DICLOENAC SODIUM and MISOPROSTOL).
What is the active ingredient?: Diclofenac sodium, Misoprostol.
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for DICLOENAC SODIUM and MISOPROSTOL DR?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
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	Bryant Ranch Prepack	71335-2603
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLdiclofenac sodium/misoprostol	Diclofenac sodium 75 mg/1; Misoprostol 200 ug/1	TabletOral	Sportpharm LLC	85766-192

DICLOENAC SODIUM and MISOPROSTOL DR (Dicloenac sodium and misoprostol) NDC 80425-0273