Diclofenac Sodium NDC 72189-319

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0319Add 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
72189-319-05	72189031905	150 mL in 1 BOTTLE, DROPPER (72189-319-05)Marketed from Jan 19, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 16.05 mg/mL
Dosage form: Solution
Route: Topical
Labeler: DirectRx
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203818
Marketing start: Jan 19, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 72189-319_4d3a583a-dad9-8766-e063-6394a90a525fSPL ID 4d3a583a-dad9-8766-e063-6394a90a525fSPL set ID d5f215d4-9aa3-2ecf-e053-2995a90a2e89RxCUI 857700UNII 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

N472189031905 followed by a unit qualifier and the quantity

Package 72189-0319-05. 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 Mar 17, 2026.

Indications (excerpt from the label)

Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms 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 203818

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

FDA NDC Directory listings under ANDA 203818
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	REMEDYREPACK INC.	70518-2811
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Asclemed USA, Inc.	76420-919
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	A-S Medication Solutions	50090-6713
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Sun Pharmaceutical Industries, Inc.	51672-1358
Diclofenac sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Proficient Rx LP	71205-062
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Direct_Rx	72189-454
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Proficient Rx LP	71205-579
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Advanced Rx of Tennessee, LLC	80425-0361
Diclofenac Sodium	Diclofenac sodium 16.05 mg/mL	SolutionTopical	Preferred Pharmaceuticals, Inc.	68788-7715