Diclofenac Sodium NDC 80425-0234

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, LLC
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)

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