What is NDC 65162-512?

65162-512 is the product NDC for Salsalate, Salsalate 500 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 65162-512 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0512Add 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
65162-512-10	65162051210	100 TABLET in 1 BOTTLE (65162-512-10)Marketed from Sep 24, 2010
65162-512-11	65162051211	1000 TABLET in 1 BOTTLE (65162-512-11)Marketed from Sep 24, 2010
65162-512-50	65162051250	500 TABLET in 1 BOTTLE (65162-512-50)Marketed from Sep 24, 2010

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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Sep 24, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 65162-512_6b990a95-3932-4771-adb1-84bfe4c456deSPL ID 6b990a95-3932-4771-adb1-84bfe4c456deSPL set ID 213f0930-4a4a-4894-90b9-70c12daaa093RxCUI 312899, 583170UNII V9MO595C9IUPC 0365162512106, 0365162513103

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

N465162051210 followed by a unit qualifier and the quantity

Package 65162-0512-10. 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 Oct 30, 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 and other treatment options before deciding to use Salsalate tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Salsalate 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 65162-512

What is NDC 65162-512?: 65162-512 is the product NDC for Salsalate, Salsalate 500 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 package NDCs, 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 750 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-616	69367-0616-01
Salsalate	Salsalate 750 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-513	65162-0513-1065162-0513-1165162-0513-50