What is NDC 80425-0564?

80425-0564 is the product NDC for Diclofenac Sodium, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, 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 Sodium?

239 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diclofenac Sodium NDC 80425-0564 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0564Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0564Add 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
80425-0564-1	80425056401	30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-1)Marketed from Dec 5, 2025
80425-0564-2	80425056402	60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-2)Marketed from Dec 5, 2025
80425-0564-3	80425056403	90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-3)Marketed from Dec 5, 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
Generic name (nonproprietary): diclofenac sodium
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 075185
Marketing start: Dec 5, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 80425-0564_4539e7df-c6cc-0550-e063-6294a90a0a2fSPL ID 4539e7df-c6cc-0550-e063-6294a90a0a2fSPL set ID 4539e9e7-5d82-3b36-e063-6394a90a1396RxCUI 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

N480425056401 followed by a unit qualifier and the quantity

Package 80425-0564-01. 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 5, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration and Perforation ) . Diclofenac is 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 80425-0564

What is NDC 80425-0564?: 80425-0564 is the product NDC for Diclofenac Sodium, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac Sodium.
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 Sodium?: 239 other product NDCs are listed under this name. See all Diclofenac Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diclofenac Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	IPG Pharmaceuticals, inc.	71085-084	71085-0084-03
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Target Corporation	11673-028	11673-0028-1011673-0028-15
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Northwind Health Company, LLC	82868-114	82868-0114-30
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4135	68788-4135-01
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	84386-103	84386-0103-01
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4694	70518-4694-00
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4118	68788-4118-01
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4335	68788-4335-01
Diclofenac Sodium	Diclofenac sodium 25 mg/1	Tablet, Delayed releaseOral	Umedica Laboratories USA Inc.	60290-082	60290-0082-01
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Umedica Laboratories USA Inc.	60290-083	60290-0083-0160290-0083-0260290-0083-03+1 more

All 240 Diclofenac Sodium NDCs

Other NDCs under ANDA 075185

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

FDA NDC Directory listings under ANDA 075185
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-1104
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Carlsbad Technology, Inc.	61442-226
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Carlsbad Technology, Inc.	61442-227
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-0481
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Northwind Health Company, LLC	51655-176
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	71205-991
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	71205-995
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Redpharm Drug	67296-2215
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8952
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	SOLA Pharmaceuticals, LLC	70512-784
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Northwind Health Company, LLC	51655-280
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4602
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	71205-494
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	RedPharm Drug, Inc.	67296-1197
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-4934
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-9806
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-4117
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-2707
Diclofenac Sodium DRdiclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0189
Diclofenac Sodium Delayed Releasediclofenac sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-7818

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