Prescription drug · BLA
Skytrofa (Lonapegsomatropin-tcgd) NDC 73362-004
Lonapegsomatropin 3.6 mg/1 · Injection, Powder, Lyophilized, For solution · Subcutaneous · Ascendis Pharma Endocrinology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73362-004-01 | 73362000401 | 4 BLISTER PACK in 1 CARTON (73362-004-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-004-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGEMarketed from Aug 25, 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)
- Skytrofa
- Generic name (nonproprietary)
- lonapegsomatropin-tcgd
- Active ingredients
- Lonapegsomatropin — 3.6 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Subcutaneous
- Labeler
- Ascendis Pharma Endocrinology, Inc.NDC labeler code 73362
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761177
- Marketing start
- Listing expires
- Other FDA classes
- Human Growth Hormone (Chemical structure)
- Identifiers
- Product ID 73362-004_4b962793-361f-4194-8292-af51f5ceaabbSPL ID 4b962793-361f-4194-8292-af51f5ceaabbSPL set ID 9229f871-bc61-4ddc-8122-d126d40e36acRxCUI 2569603, 2569605, 2569607, 2569609, 2569611, 2569613, 2569615, 2569617, 2569619, 2569621, 2569623, 2569625, 2569627, 2569629, 2569631, 2569633, 2569635, 2569637, 2721785, 2721787, 2721789, 2721791, 2721793, 2721795, 2721797, 2721799, 2721801, 2721803UNII OP35X9610Y
- Pharmacologic class
- Recombinant Human Growth Hormone
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
N473362000401followed by a unit qualifier and the quantityPackage 73362-0004-01. 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 .
Indications (excerpt from the label)
SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone indicated for: Pediatric Patients: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 73362-004
- What is NDC 73362-004?
- 73362-004 is the product NDC for Skytrofa (lonapegsomatropin-tcgd), Lonapegsomatropin 3.6 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Ascendis Pharma Endocrinology, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Skytrofa (Lonapegsomatropin-tcgd).
- What is the active ingredient?
- Lonapegsomatropin.
- Who is the labeler?
- Ascendis Pharma Endocrinology, Inc., NDC labeler code 73362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Skytrofa?
- 13 other product NDCs are listed under this name. See all Skytrofa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Skytrofa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin .7 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-012 | 73362-0012-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 1.4 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-013 | 73362-0013-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 1.8 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-014 | 73362-0014-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 2.1 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-015 | 73362-0015-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 2.5 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-016 | 73362-0016-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-003 | 73362-0003-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 4.3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-005 | 73362-0005-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 5.2 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-006 | 73362-0006-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 6.3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-007 | 73362-0007-01 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 7.6 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-008 | 73362-0008-01 |
Other NDCs under BLA 761177
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-003 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 4.3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-005 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 5.2 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-006 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 6.3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-007 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 7.6 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-008 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 9.1 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-009 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 11 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-010 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 13.3 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-011 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin .7 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-012 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 1.4 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-013 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 1.8 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-014 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 2.1 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-015 |
| Skytrofalonapegsomatropin-tcgd | Lonapegsomatropin 2.5 mg/1 | Injection, Powder, Lyophilized, For solutionSubcutaneous | Ascendis Pharma Endocrinology, Inc. | 73362-016 |