What is NDC 75834-338?

75834-338 is the product NDC for Diclofenac Potassium, Diclofenac potassium 50 mg/1 powder, for solution, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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 Potassium?

67 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diclofenac Potassium NDC 75834-338

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-338Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0338Add 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
75834-338-01	7583403380175834033801	1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01)Marketed from Dec 15, 2025
75834-338-02	7583403380275834033802	9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02)Marketed from Dec 15, 2025

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 Potassium
Generic name (nonproprietary): diclofenac potassium
Active ingredients: Diclofenac potassium — 50 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: Nivagen Pharmaceuticals, Inc.NDC labeler code 75834
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217010
Marketing start: Dec 15, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 75834-338_46982e49-ee38-ad56-e063-6394a90a2816SPL ID 46982e49-ee38-ad56-e063-6394a90a2816SPL set ID eb52a015-23cd-40f6-bf83-6749fc34947cRxCUI 859063UNII L4D5UA6CB4
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N475834033801 followed by a unit qualifier and the quantity

Package 75834-0338-01. 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 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine. The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population. Diclofenac potassium for oral solution is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older ( 1 ) Limitations of Us…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75834-338

What is NDC 75834-338?: 75834-338 is the product NDC for Diclofenac Potassium, Diclofenac potassium 50 mg/1 powder, for solution, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac Potassium.
What is the active ingredient?: Diclofenac potassium.
Who is the labeler?: Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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 Potassium?: 67 other product NDCs are listed under this name. See all Diclofenac Potassium 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 Potassium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Potassium	Diclofenac potassium 75 mg/1	Tablet, CoatedOral	Advagen Pharma Ltd	72888-203	72888-0203-0072888-0203-0172888-0203-05+1 more
Diclofenac Potassiumdiclofenac potassium, film coated	Diclofenac potassium 50 mg/1	TabletOral	Amerisyn LLC	87564-011	87564-0011-10
Diclofenac Potassiumdiclofenac potassium, film coated	Diclofenac potassium 50 mg/1	TabletOral	VICI Pharmaceuticals, Inc	87528-001	87528-0001-10
Diclofenac Potassiumdiclofenac potassium 25 mg	Diclofenac potassium 25 mg/1	Capsule, Liquid filledOral	PureTek Corporation	59088-131	59088-0131-73
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Powder, For solutionOral	Umedica Laboratories USA Inc.	60290-061	60290-0061-0160290-0061-02
Diclofenac Potassiumdiclofenac potassium tablets	Diclofenac potassium 25 mg/1	Tablet, Film coatedOral	NIVAGEN PHARMACEUTICALS, INC.	75834-337	75834-0337-3075834-0337-60
Diclofenac Potassiumdiclofenac potassium, film coated	Diclofenac potassium 25 mg/1	TabletOral	Happy Robin, LLC	87127-802	87127-0802-60
Diclofenac Potassium	Diclofenac potassium 25 mg/1	Capsule, Liquid filledOral	Lifsa Drugs LLC	72336-432	72336-0432-12
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8411	68788-8411-0168788-8411-0368788-8411-06+1 more
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-806	10135-0806-01

All 68 Diclofenac Potassium NDCs

Other NDCs under ANDA 217010

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

FDA NDC Directory listings under ANDA 217010
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Powder, For solutionOral	Umedica Laboratories USA Inc.	60290-061