NDC codes

FDA NDC Directory
Product NDC (as listed)55111-680Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0680Add 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 NDC11-digit (billing)PackageCopy
55111-680-02551110680022 SYRINGE in 1 CARTON (55111-680-02) / .6 mL in 1 SYRINGE (55111-680-11)Marketed from Jul 14, 2011
55111-680-105511106801010 SYRINGE in 1 CARTON (55111-680-10) / .6 mL in 1 SYRINGE (55111-680-11)Marketed from Jul 14, 2011

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 — 7.5 mg/.6mL
Dosage form
Injection
Route
Subcutaneous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091316
Marketing start
Listing expires
Other FDA classes
Factor Xa Inhibitors (Mechanism)
Identifiers
Product ID 55111-680_2a3f9c6b-885b-843d-9cc8-3eb67395fbdaSPL ID 2a3f9c6b-885b-843d-9cc8-3eb67395fbdaSPL set ID 49e0d7bc-3f49-849b-c77c-98682d1c0d19RxCUI 861356, 861360, 861363, 861365UNII X0Q6N9USOZ
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

N455111068002 followed by a unit qualifier and the quantity

Package 55111-0680-02. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 091316

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

FDA NDC Directory listings under ANDA 091316
ProductStrengthForm · routeLabelerProduct NDC
Fondaparinux SodiumFondaparinux sodium 5 mg/.4mLInjectionSubcutaneousDr. Reddy's Laboratories Limited55111-679
Fondaparinux SodiumFondaparinux sodium 2.5 mg/.5mLInjectionSubcutaneousDr. Reddy's Laboratories Limited55111-678
Fondaparinux SodiumFondaparinux sodium 10 mg/.8mLInjectionSubcutaneousDr. Reddy's Laboratories Limited55111-681

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