NDC codes

FDA NDC Directory
Product NDC (as listed)73683-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73683-0101Add 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
73683-101-1073683010110736830101101 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBEMarketed from Mar 23, 2022

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)
Hyftor
Generic name (nonproprietary)
sirolimus
Active ingredients
Sirolimus — 2 mg/g
Dosage form
Gel
Route
Topical
Labeler
Nobelpharma America, LLCNDC labeler code 73683
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213478
Marketing start
Listing expires
Other FDA classes
Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers
Product ID 73683-101_3cf7f2ef-f144-0632-e063-6394a90a9b9cSPL ID 3cf7f2ef-f144-0632-e063-6394a90a9b9cSPL set ID edb3ea90-5adc-48ec-99f5-ab963e302f18RxCUI 2596864, 2596869UNII W36ZG6FT64
Pharmacologic class
Kinase Inhibitor; mTOR Inhibitor Immunosuppressant

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N473683010110 followed by a unit qualifier and the quantity

Package 73683-0101-10. 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)

HYFTOR is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. HYFTOR is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73683-101

What is NDC 73683-101?
73683-101 is the product NDC for Hyftor (sirolimus), Sirolimus 2 mg/g gel, listed with the FDA by Nobelpharma America, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hyftor (Sirolimus).
What is the active ingredient?
Sirolimus.
Who is the labeler?
Nobelpharma America, LLC, NDC labeler code 73683. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hyftor?
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.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in