Prescription drug · BLA
Vimizim (Elosulfase alfa) NDC 68135-100
Elosulfase alfa 5 mg/5mL · Injection, Solution, Concentrate · Intravenous · BioMarin Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68135-100-01 | 68135010001 | 1 VIAL in 1 CARTON (68135-100-01) / 5 mL in 1 VIALMarketed from Feb 14, 2014 |
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)
- Vimizim
- Generic name (nonproprietary)
- elosulfase alfa
- Active ingredients
- Elosulfase alfa — 5 mg/5mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- BioMarin Pharmaceutical Inc.NDC labeler code 68135
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125460
- Marketing start
- Listing expires
- Other FDA classes
- alpha-Glucosidases (Chemical structure)
- Identifiers
- Product ID 68135-100_d3f50b07-ab7c-4922-83b5-6441be0c3c11SPL ID d3f50b07-ab7c-4922-83b5-6441be0c3c11SPL set ID 0caa2565-12b2-0ad0-1f9a-273e81c3d4ccRxCUI 1490047, 1490052UNII ODJ69JZG85
- 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.
- NDC on a medical claim
N468135010001followed by a unit qualifier and the quantityPackage 68135-0100-01. 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)
VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68135-100
- What is NDC 68135-100?
- 68135-100 is the product NDC for Vimizim (elosulfase alfa), Elosulfase alfa 5 mg/5mL injection, solution, concentrate, listed with the FDA by BioMarin Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vimizim (Elosulfase alfa).
- What is the active ingredient?
- Elosulfase alfa.
- Who is the labeler?
- BioMarin Pharmaceutical Inc., NDC labeler code 68135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vimizim?
- 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.