What is NDC 80425-0056?

80425-0056 is the product NDC for Diclofenac DR (diclofenac), Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx 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 Diclofenac 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.

Diclofenac DR NDC 80425-0056 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0056Add 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
80425-0056-1	8042500560180425005601	60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0056-1)Marketed from Aug 19, 2008

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 DRSuffix: DR
Generic name (nonproprietary): diclofenac
Active ingredients: Diclofenac sodium — 75 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077863
Marketing start: Aug 19, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 80425-0056_2a98d0b7-639a-da12-e063-6294a90a2a7eSPL ID 2a98d0b7-639a-da12-e063-6294a90a2a7eSPL set ID af8a30fb-ead8-7e29-e053-2a95a90a040fRxCUI 855926UNII QTG126297Q
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N480425005601 followed by a unit qualifier and the quantity

Package 80425-0056-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Indications and Usage Section INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION AND PERFORATION). Diclofenac sodium delayed-release tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0056

What is NDC 80425-0056?: 80425-0056 is the product NDC for Diclofenac DR (diclofenac), Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac DR (Diclofenac).
What is the active ingredient?: Diclofenac sodium.
Who is the labeler?: Advanced Rx 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 Diclofenac 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 077863

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

FDA NDC Directory listings under ANDA 077863
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Rising Pharma Holdings, Inc.	16571-201
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-6924
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	American Health Packaging	60687-658
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	St. Mary's Medical Park Pharmacy	60760-090
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	63187-012
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	66267-071
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Coupler LLC	67046-1482
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	BluePoint Laboratories	68001-281
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8193
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-0456
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-578
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-670
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	PHOENIX RX LLC	85509-1201
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Sportpharm LLC	85766-010

Diclofenac DR (Diclofenac) NDC 80425-0056