Prescription drug · BLA
Elelyso (Taliglucerase alfa) NDC 0069-0106
Taliglucerase alfa 200 U/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0106-01 | 00069010601 | 1 VIAL, GLASS in 1 CARTON (0069-0106-01) / 5 mL in 1 VIAL, GLASSMarketed from May 1, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Elelyso
- Generic name (nonproprietary)
- taliglucerase alfa
- Active ingredients
- Taliglucerase alfa — 200 U/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 022458
- Marketing start
- Listing expires
- Other FDA classes
- Glucosylceramidase (Chemical structure)
- Identifiers
- Product ID 0069-0106_d7eb51c8-fe18-46f2-8d97-eaa343ec8821SPL ID d7eb51c8-fe18-46f2-8d97-eaa343ec8821SPL set ID fa3cbd5d-677c-4b19-9032-d9182cb69a83RxCUI 1292879, 1292881UNII 0R4NLX88O4
- Pharmacologic class
- Hydrolytic Lysosomal Glucocerebroside-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.
- NDC on a medical claim
N400069010601followed by a unit qualifier and the quantityPackage 00069-0106-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0069-0106
- What is NDC 0069-0106?
- 0069-0106 is the product NDC for Elelyso (taliglucerase alfa), Taliglucerase alfa 200 U/5mL injection, powder, lyophilized, for solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Elelyso (Taliglucerase alfa).
- What is the active ingredient?
- Taliglucerase alfa.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Elelyso?
- 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.