What is NDC 54092-700?

54092-700 is the product NDC for Elaprase (idursulfase), Idursulfase 6 mg/3mL solution, concentrate, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Elaprase?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Elaprase NDC 54092-700 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54092-700Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54092-0700Add 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
54092-700-01	5409207000154092070001	1 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASSMarketed from Jul 24, 2006

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): Elaprase
Generic name (nonproprietary): idursulfase
Active ingredients: Idursulfase — 6 mg/3mL
Dosage form: Solution, Concentrate
Route: Intravenous
Labeler: Takeda Pharmaceuticals America, Inc.NDC labeler code 54092
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125151
Marketing start: Jul 24, 2006
Listing expires: Dec 31, 2026
Other FDA classes: alpha-Glucosidases (Chemical structure)
Identifiers: Product ID 54092-700_25f45811-e646-4342-9954-d8220cadf886SPL ID 25f45811-e646-4342-9954-d8220cadf886SPL set ID 60cba843-5aab-4dd7-96dc-66648d413be3RxCUI 644104, 647118UNII 5W8JGG2651
Pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

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

N454092070001 followed by a unit qualifier and the quantity

Package 54092-0700-01. 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 Apr 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4) ]. ELAPRASE is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54092-700

What is NDC 54092-700?: 54092-700 is the product NDC for Elaprase (idursulfase), Idursulfase 6 mg/3mL solution, concentrate, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Elaprase (Idursulfase).
What is the active ingredient?: Idursulfase.
Who is the labeler?: Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Elaprase?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Elaprase (Idursulfase) NDC 54092-700