What is NDC 52958-034?

52958-034 is the product NDC for Bivalirudin, Bivalirudin 250 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hainan Shuangcheng Pharmaceuticals Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hainan Shuangcheng Pharmaceuticals Co., Ltd., NDC labeler code 52958. 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 52958-034 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)52958-034Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52958-0034Add 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
52958-034-01	5295800340152958003401	10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Oct 23, 2019

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, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Hainan Shuangcheng Pharmaceuticals Co., Ltd.NDC labeler code 52958
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210031
Marketing start: Oct 23, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 52958-034_463422b6-e6d2-4319-a95e-aed834c2c844SPL ID 463422b6-e6d2-4319-a95e-aed834c2c844SPL set ID 61de12ff-e280-4bab-9804-43869ec45fa7RxCUI 308769UNII TN9BEX005GUPC 0352958034010
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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N452958003401 followed by a unit qualifier and the quantity

Package 52958-0034-01. 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 23, 2024.

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 52958-034

What is NDC 52958-034?: 52958-034 is the product NDC for Bivalirudin, Bivalirudin 250 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hainan Shuangcheng Pharmaceuticals Co., Ltd.. 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?: Hainan Shuangcheng Pharmaceuticals Co., Ltd., NDC labeler code 52958. 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/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
Bivalirudin	Bivalirudin 250 mg/1	InjectionIntracavernous	Dr. Reddy's Laboratories Limited	55111-652	55111-0652-37

All 13 Bivalirudin NDCs

Other NDCs under ANDA 210031

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

FDA NDC Directory listings under ANDA 210031
Product	Strength	Form · route	Labeler	Product NDC
Bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Avenacy, LLC	83634-400