NDC codes

FDA NDC Directory
Product NDC (as listed)68135-181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68135-0181Add 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
68135-181-93681350181931 KIT in 1 CARTON (68135-181-93) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92) / .6 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-158-17)Marketed from Nov 19, 2021

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)
VOXZOGO 1.2mg
Generic name (nonproprietary)
vosoritide
Dosage form
Kit
Labeler
BioMarin Pharmaceutical Inc.NDC labeler code 68135
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 214938
Marketing start
Listing expires
Identifiers
Product ID 68135-181_6100caa6-4951-4773-b80c-6be0c04efd24SPL ID 6100caa6-4951-4773-b80c-6be0c04efd24SPL set ID 228e8560-04a4-4bb1-a81f-29531a9e4d27RxCUI 2586364, 2586369, 2586371, 2586373, 2586375, 2586377

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

N468135018193 followed by a unit qualifier and the quantity

Package 68135-0181-93. 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 .

Indications (excerpt from the label)

VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). VOXZOGO is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be conti…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68135-181

What is NDC 68135-181?
68135-181 is the product NDC for VOXZOGO 1.2mg (vosoritide) kit, 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?
VOXZOGO 1.2mg (Vosoritide).
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 VOXZOGO 1.2mg?
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.

Other NDCs under NDA 214938

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

FDA NDC Directory listings under NDA 214938
ProductStrengthForm · routeLabelerProduct NDC
VOXZOGO 0.4mgvosoritide—KitBioMarin Pharmaceutical Inc.68135-082
VOXZOGO 0.56mgvosoritide—KitBioMarin Pharmaceutical Inc.68135-119

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