Diclofenac Sodium NDC 82804-113

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-113Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0113Add 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
82804-113-12	82804011312	1 BOTTLE, PUMP in 1 CARTON (82804-113-12) / 112 g in 1 BOTTLE, PUMPMarketed from Jul 5, 2024

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 — 20 mg/g
Dosage form: Solution
Route: Topical
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208021
Marketing start: Feb 19, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 82804-113_898558e7-17f8-40cd-9dfc-67ddd64a5a42SPL ID 898558e7-17f8-40cd-9dfc-67ddd64a5a42SPL set ID 898558e7-17f8-40cd-9dfc-67ddd64a5a42RxCUI 1487074UNII QTG126297QUPC 0382804113125
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

N482804011312 followed by a unit qualifier and the quantity

Package 82804-0113-12. 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 Jul 1, 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 ) Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208021

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

FDA NDC Directory listings under ANDA 208021
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Advanced Rx of Tennessee, LLC	80425-0405
Diclofenac Sodium	Diclofenac sodium 20 mg/g	SolutionTopical	ASCLEMED USA INC.	87063-223
Diclofenac Sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Preferred Pharmaceuticals Inc.	68788-8743
Diclofenac Sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Lupin Pharmaceuticals, Inc.	68180-537
Diclofenac Sodium	Diclofenac sodium 20 mg/g	SolutionTopical	PHOENIX RX LLC	85509-1537
Diclofenac Sodium Topical Solution	Diclofenac sodium 20 mg/g	SolutionTopical	Direct_Rx	72189-575