Diclofenac sodium NDC 80425-0337

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0337Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0337Add 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
80425-0337-1	80425033701	1 BOTTLE, PUMP in 1 CARTON (80425-0337-1) / 112 g in 1 BOTTLE, PUMPMarketed from May 19, 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 — 20 mg/g
Dosage form: Solution
Route: Topical
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212506
Marketing start: May 19, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 80425-0337_2a9c0c91-2b36-4def-e063-6294a90a58efSPL ID 2a9c0c91-2b36-4def-e063-6294a90a58efSPL set ID fc0e1950-d76f-75bc-e053-6294a90a8c12RxCUI 1487074UNII 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

N480425033701 followed by a unit qualifier and the quantity

Package 80425-0337-01. 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)

Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212506

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

FDA NDC Directory listings under ANDA 212506
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Alembic Pharmaceuticals Inc.	62332-487
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	AvKARE	42291-055
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Alembic Pharmaceuticals Limited	46708-487
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Quality Care Products, LLC	83008-019