What is NDC 69367-616?

69367-616 is the product NDC for Salsalate, Salsalate 750 mg/1 tablet, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Salsalate?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Salsalate NDC 69367-616 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0616Add 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
69367-616-01	69367061601	100 TABLET in 1 BOTTLE (69367-616-01)Marketed from Nov 15, 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): Salsalate
Generic name (nonproprietary): salsalate
Active ingredients: Salsalate — 750 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Westminster Pharmaceuticals, LLCNDC labeler code 69367
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Nov 15, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 69367-616_56747829-5049-405d-8d69-83c34d70002bSPL ID 56747829-5049-405d-8d69-83c34d70002bSPL set ID 24815546-658b-4b01-ac11-de7fbd0ebd16RxCUI 312899, 583170UNII V9MO595C9IUPC 0369367615013, 0369367616010

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

N469367061601 followed by a unit qualifier and the quantity

Package 69367-0616-01. 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 Feb 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Salsalate, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69367-616

What is NDC 69367-616?: 69367-616 is the product NDC for Salsalate, Salsalate 750 mg/1 tablet, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Salsalate.
What is the active ingredient?: Salsalate.
Who is the labeler?: Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Salsalate?: 3 other product NDCs are listed under this name. See all Salsalate 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 Salsalate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Salsalate	Salsalate 500 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-615	69367-0615-01
Salsalate	Salsalate 500 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-512	65162-0512-1065162-0512-1165162-0512-50
Salsalate	Salsalate 750 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-513	65162-0513-1065162-0513-1165162-0513-50