What is NDC 72189-473?

72189-473 is the product NDC for Diclofenac Sodium Gel, Diclofenac sodium 30 mg/g gel, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 Gel?

2 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 Gel NDC 72189-473

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-473Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0473Add 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
72189-473-01	7218904730172189047301	1 g in 1 TUBE (72189-473-01)Marketed from May 19, 2023

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 Gel
Generic name (nonproprietary): diclofenac sodium gel
Active ingredients: Diclofenac sodium — 30 mg/g
Dosage form: Gel
Route: Topical
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212351
Marketing start: May 19, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 72189-473_4d3a6fe8-20c4-50fe-e063-6294a90affcfSPL ID 4d3a6fe8-20c4-50fe-e063-6294a90affcfSPL set ID fc0c9cfe-998b-d22a-e053-6294a90afa42RxCUI 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

N472189047301 followed by a unit qualifier and the quantity

Package 72189-0473-01. 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 Mar 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-473

What is NDC 72189-473?: 72189-473 is the product NDC for Diclofenac Sodium Gel, Diclofenac sodium 30 mg/g gel, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac Sodium Gel.
What is the active ingredient?: Diclofenac sodium.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 Gel?: 2 other product NDCs are listed under this name. See all Diclofenac Sodium Gel 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 Gel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Sodium Gel	Diclofenac sodium 10 mg/g	GelTopical	Direct_Rx	72189-479	72189-0479-01
Diclofenac Sodium Gel	Diclofenac sodium 30 mg/g	GelTopical	Direct_Rx	72189-379	72189-0379-01

Other NDCs under ANDA 212351

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

FDA NDC Directory listings under ANDA 212351
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	Medsource Pharmaceuticals	45865-260
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-581
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-581
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-8456
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	REMEDYREPACK INC.	70518-3779
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0338
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	Proficient Rx LP	82804-250
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	PHOENIX RX LLC	85509-1581
Diclofenac Sodiumdiclofenac sodium topical	Diclofenac sodium 30 mg/g	GelTopical	ASCLEMED USA INC.	87063-165