What is NDC 55111-652?

55111-652 is the product NDC for Bivalirudin, Bivalirudin 250 mg/1 injection, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bivalirudin?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bivalirudin NDC 55111-652 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-652Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0652Add 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
55111-652-37	5511106523755111065237	10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)Marketed from May 31, 2017

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): Bivalirudin
Generic name (nonproprietary): bivalirudin
Active ingredients: Bivalirudin — 250 mg/1
Dosage form: Injection
Route: Intracavernous
Labeler: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201577
Marketing start: May 31, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69SPL ID 2c95d0ae-12a5-4981-d4cf-99e26a7f5a69SPL set ID 19beb2ae-6064-3c24-fe50-0cee86896979RxCUI 308769UNII TN9BEX005G
Pharmacologic class: Anti-coagulant; Direct Thrombin Inhibitor

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N455111065237 followed by a unit qualifier and the quantity

Package 55111-0652-37. 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 Jul 16, 2019.

Indications (excerpt from the label)

Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention(PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-652

What is NDC 55111-652?: 55111-652 is the product NDC for Bivalirudin, Bivalirudin 250 mg/1 injection, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bivalirudin.
What is the active ingredient?: Bivalirudin.
Who is the labeler?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bivalirudin?: 12 other product NDCs are listed under this name. See all Bivalirudin 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 Bivalirudin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bivalirudin	Bivalirudin 250 mg/1	Injection, SolutionIntravenous	MAIA Pharmaceuticals, Inc.	70511-142	70511-0142-5070511-0142-84
Bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Avenacy, LLC	83634-400	83634-0400-10
Bivalirudin	Bivalirudin 250 mg/1	Injection, SolutionIntravenous	Par Health USA, LLC	42023-622	42023-0622-0142023-0622-10
bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For suspensionIntravenous	Slate Run Pharmaceuticals, LLC	70436-025	70436-0025-8070436-0025-82
bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Civica, Inc.	72572-035	72572-0035-10
Bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-034	52958-0034-01
Bivalirudin	Bivalirudin 250 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Accord Healthcare, Inc.	16729-275	16729-0275-67
Bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-210	55150-0210-10
Bivalirudin	Bivalirudin 250 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-427	71288-0427-11
Bivalirudin	Bivalirudin 250 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Mylan Institutional LLC	67457-256	67457-0256-10

All 13 Bivalirudin NDCs