What is NDC 42291-055?

42291-055 is the product NDC for Diclofenac sodium, Diclofenac sodium 20 mg/g solution, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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?

239 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 NDC 42291-055 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-055Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0055Add 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
42291-055-12	42291005512	1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMPMarketed from Aug 29, 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
Generic name (nonproprietary): diclofenac sodium
Active ingredients: Diclofenac sodium — 20 mg/g
Dosage form: Solution
Route: Topical
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212506
Marketing start: Aug 29, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 42291-055_484c1f52-6419-1ce3-e063-6394a90aa297SPL ID 484c1f52-6419-1ce3-e063-6394a90aa297SPL set ID 0416ce03-c345-9d9e-e063-6294a90ad940RxCUI 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

N442291005512 followed by a unit qualifier and the quantity

Package 42291-0055-12. 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 Jan 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). 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)

About NDC 42291-055

What is NDC 42291-055?: 42291-055 is the product NDC for Diclofenac sodium, Diclofenac sodium 20 mg/g solution, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac sodium.
What is the active ingredient?: Diclofenac sodium.
Who is the labeler?: AvKARE, NDC labeler code 42291. 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?: 239 other product NDCs are listed under this name. See all Diclofenac sodium 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	IPG Pharmaceuticals, inc.	71085-084	71085-0084-03
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Target Corporation	11673-028	11673-0028-1011673-0028-15
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Northwind Health Company, LLC	82868-114	82868-0114-30
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4135	68788-4135-01
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	84386-103	84386-0103-01
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4694	70518-4694-00
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4118	68788-4118-01
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4335	68788-4335-01
Diclofenac Sodium	Diclofenac sodium 25 mg/1	Tablet, Delayed releaseOral	Umedica Laboratories USA Inc.	60290-082	60290-0082-01
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Umedica Laboratories USA Inc.	60290-083	60290-0083-0160290-0083-0260290-0083-03+1 more

All 240 Diclofenac sodium NDCs

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 Limited	46708-487
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0337
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Quality Care Products, LLC	83008-019
Diclofenac sodium	Diclofenac sodium 20 mg/g	SolutionTopical	Alembic Pharmaceuticals Inc.	62332-487