In short

CMS assigns Bivalirudin NDCs to 2 HCPCS codes: J0582 (per 1 mg), J0583 (per 1 mg). Which one applies depends on the product; the table lists each NDC with its code.

J0582 code detailsJ0583 code details

Reference

J0582
Injection, bivalirudin (endo), not therapeutically equivalent to j0583, 1 mgBilling unit: 1 mg
J0583
Injection, bivalirudin, 1 mgBilling unit: 1 mg
Labelers
Accord Healthcare Inc; Avenacy Inc.; Civica, Inc.; Dr. Reddy's Laboratories Inc.; Endo USA, Inc.; Eugia US LLC; FreseniUS Kabi USA, LLC; Meitheal Pharmaceuticals Inc.and 3 more

Medicare Part B payment limit

CMS ASP file
Payment limit per unit$0.168
Per1 mg
Coinsurance20%

Effective October 1, 2026 through December 31, 2026. Payment allowance limits subject to the ASP methodology are based on 2Q26 ASP data. A payment limit is not a coverage decision; the Medicare contractor decides coverage. CMS ASP pricing files

Medicare Part B payment limit

CMS ASP file
Payment limit per unit$0.165
Per1 mg
Coinsurance20%

Effective October 1, 2026 through December 31, 2026. Payment allowance limits subject to the ASP methodology are based on 2Q26 ASP data. A payment limit is not a coverage decision; the Medicare contractor decides coverage. CMS ASP pricing files

Bivalirudin units and claim line

Enter the dose given to get the J0582 units and the NDC line for the CMS-1500 and the 837P. This builds the J0582 line; use the code page for J0583.

Enter the dose given to build the claim line.

Bivalirudin NDCs and billing units

From CMS’s ASP NDC–HCPCS crosswalk, effective October 1, 2026 through December 31, 2026. Billing units per package are CMS’s figures for the code’s unit.

Bivalirudin NDCs in the CMS ASP crosswalk
NDC (11-digit)HCPCSLabelerPackageBilling units per package
42023-0622-10J0582Endo USA, Inc.10 × 502500
00781-3158-95J0583Sandoz Inc.10 × 12500
00781-9158-95J0583Sandoz Inc.10 × 12500
16729-0275-67J0583Accord Healthcare Inc10 × 12500
55111-0652-37J0583Dr. Reddy's Laboratories Inc.10 × 12500
55150-0210-10J0583Eugia US LLC10 × 12500
63323-0562-10J0583FreseniUS Kabi USA, LLC10 × 12500
63323-0562-15J0583FreseniUS Kabi USA, LLC10 × 12500
67457-0256-10J0583Mylan Institutional LLC10 × 12500
70436-0025-82J0583Slate Run Pharmaceuticals10 × 12500
71288-0427-11J0583Meitheal Pharmaceuticals Inc.10 × 12500
71288-0427-92J0583Meitheal Pharmaceuticals Inc.10 × 12500
72572-0035-10J0583Civica, Inc.10 × 12500
83634-0400-10J0583Avenacy Inc.10 × 12500

Bivalirudin: common questions

What is the J-code for Bivalirudin?
CMS assigns Bivalirudin NDCs to 2 HCPCS codes: J0582 (per 1 mg), J0583 (per 1 mg). Which one applies depends on the product; the table lists each NDC with its code.
How many J0582 billing units are in a package of Bivalirudin?
CMS lists 2,500 billing units per package, depending on the NDC, where one unit is 1 mg. Units to report are based on the dose given, not the package.
How many J0583 billing units are in a package of Bivalirudin?
CMS lists 2,500 billing units per package, depending on the NDC, where one unit is 1 mg. Units to report are based on the dose given, not the package.
Is J0582 a CPT code?
No. J0582 is a HCPCS Level II code from CMS for the drug itself. Giving it, for example by injection or infusion, is usually reported with a separate CPT administration code.

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