Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)68135-020Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68135-0020Add 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
68135-020-99681350020996813500209920000 mL in 1 BAG (68135-020-99)Marketed from 09-JUN-05

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

Generic name (nonproprietary)
galsulfase
Active ingredients
Galsulfase — 5 mg/5mL
Dosage form
Solution
Labeler
BioMarin Pharmaceutical Inc.NDC labeler code 68135
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
Identifiers
Product ID 68135-020_4204adef-3c1b-4818-96f2-3fcf66fe8719SPL ID 4204adef-3c1b-4818-96f2-3fcf66fe8719

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.

NDC on a medical claim

N468135002099 followed by a unit qualifier and the quantity

Package 68135-0020-99. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68135-020

What is NDC 68135-020?
68135-020 is the product NDC for galsulfase, Galsulfase 5 mg/5mL solution, 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?
galsulfase.
What is the active ingredient?
Galsulfase.
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 galsulfase?
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.

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