What is NDC 11797-157?

11797-157 is the product NDC for fondaparinux sodium, Fondaparinux sodium 10 mg/.8mL injection, solution, listed with the FDA by Italfarmaco S.p.A. It has 2 package NDCs, shown above in 10- and 11-digit form.

Italfarmaco S.p.A, NDC labeler code 11797. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for fondaparinux sodium?

23 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

fondaparinux sodium NDC 11797-157 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11797-157Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11797-0157Add 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
11797-157-06	1179701570611797015706	10 SYRINGE in 1 CARTON (11797-157-06) / .8 mL in 1 SYRINGE (11797-157-02)Marketed from Feb 6, 2019
11797-157-09	1179701570911797015709	2 SYRINGE in 1 CARTON (11797-157-09) / .8 mL in 1 SYRINGE (11797-157-02)Marketed from Feb 6, 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): fondaparinux sodium
Generic name (nonproprietary): fondaparinux sodium
Active ingredients: Fondaparinux sodium — 10 mg/.8mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Italfarmaco S.p.ANDC labeler code 11797
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208615
Marketing start: Feb 6, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Factor Xa Inhibitors (Mechanism)
Identifiers: Product ID 11797-157_714aaf0c-95ac-4de9-b8d2-5fdcd1365804SPL ID 714aaf0c-95ac-4de9-b8d2-5fdcd1365804SPL set ID 58789e3d-e5bc-4c2e-a527-495a252fcecdRxCUI 861356, 861360, 861363, 861365UNII X0Q6N9USOZUPC 0311797154068, 0311797154099, 0311797156062, 0311797155096, 0311797156093, 0311797157069, 0311797157090, 0311797155065
Pharmacologic class: Factor Xa 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

N411797015706 followed by a unit qualifier and the quantity

Package 11797-0157-06. 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, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. ( 1.1 ) Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin. ( 1.2 , 1.3 ) 1.1 Prophylaxis of Deep Vein Thrombosis Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing hip fracture surgery, including extended prophylaxis; in patients undergoing hip replacement surgery;…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11797-157

What is NDC 11797-157?: 11797-157 is the product NDC for fondaparinux sodium, Fondaparinux sodium 10 mg/.8mL injection, solution, listed with the FDA by Italfarmaco S.p.A. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: fondaparinux sodium.
What is the active ingredient?: Fondaparinux sodium.
Who is the labeler?: Italfarmaco S.p.A, NDC labeler code 11797. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for fondaparinux sodium?: 23 other product NDCs are listed under this name. See all fondaparinux sodium 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 fondaparinux sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fondaparinux Sodium	Fondaparinux sodium 2.5 mg/.5mL	InjectionSubcutaneous	Sandoz Inc.	0781-3443	00781-3443-1200781-3443-95
Fondaparinux Sodium	Fondaparinux sodium 5 mg/.4mL	InjectionSubcutaneous	Sandoz Inc.	0781-3454	00781-3454-1200781-3454-95
Fondaparinux Sodium	Fondaparinux sodium 7.5 mg/.6mL	InjectionSubcutaneous	Sandoz Inc.	0781-3465	00781-3465-1200781-3465-95
Fondaparinux Sodium	Fondaparinux sodium 10 mg/.8mL	InjectionSubcutaneous	Sandoz Inc.	0781-3476	00781-3476-1200781-3476-95
fondaparinux sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-154	11797-0154-0611797-0154-09
fondaparinux sodium	Fondaparinux sodium 5 mg/.4mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-155	11797-0155-0611797-0155-09
fondaparinux sodium	Fondaparinux sodium 7.5 mg/.6mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-156	11797-0156-0611797-0156-09
fondaparinux sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1514	70710-1514-0670710-1514-09
fondaparinux sodium	Fondaparinux sodium 5 mg/.4mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1515	70710-1515-0670710-1515-09
fondaparinux sodium	Fondaparinux sodium 7.5 mg/.6mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1516	70710-1516-0670710-1516-09

All 24 fondaparinux sodium NDCs

Other NDCs under ANDA 208615

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

FDA NDC Directory listings under ANDA 208615
Product	Strength	Form · route	Labeler	Product NDC
fondaparinux sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-154
fondaparinux sodium	Fondaparinux sodium 5 mg/.4mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-155
fondaparinux sodium	Fondaparinux sodium 7.5 mg/.6mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-156
fondaparinux sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1514
fondaparinux sodium	Fondaparinux sodium 5 mg/.4mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1515
fondaparinux sodium	Fondaparinux sodium 7.5 mg/.6mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1516
fondaparinux sodium	Fondaparinux sodium 10 mg/.8mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1517