What is NDC 80425-0234?

80425-0234 is the product NDC for Diclofenac Sodium, Diclofenac sodium 30 mg/g gel, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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 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 80425-0234 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0234Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0234Add 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
80425-0234-1	80425023401	1 TUBE in 1 CARTON (80425-0234-1) / 100 g in 1 TUBEMarketed from Jan 9, 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): Diclofenac Sodium
Generic name (nonproprietary): diclofenac sodium
Active ingredients: Diclofenac sodium — 30 mg/g
Dosage form: Gel
Route: Topical
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200936
Marketing start: Jan 9, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 80425-0234_2a9b7c00-167e-4da0-e063-6394a90a926dSPL ID 2a9b7c00-167e-4da0-e063-6394a90a926dSPL set ID f187ae44-71be-a682-e053-2995a90a6426RxCUI 855642UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425023401 followed by a unit qualifier and the quantity

Package 80425-0234-01. 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.

Indications (excerpt from the label)

Indications and Usage Diclofenac Sodium Gel, 3% is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0234

What is NDC 80425-0234?: 80425-0234 is the product NDC for Diclofenac Sodium, Diclofenac sodium 30 mg/g gel, 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?: Diclofenac Sodium.
What is the active ingredient?: Diclofenac sodium.
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 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 200936

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

FDA NDC Directory listings under ANDA 200936
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Asclemed USA, Inc.	76420-025