Prescription drug · NDA
Hyftor (Sirolimus) NDC 73683-101
Sirolimus 2 mg/g · Gel · Topical · Nobelpharma America, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73683-101-10 | 7368301011073683010110 | 1 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
N473683010110followed by a unit qualifier and the quantityPackage 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.
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.