Prescription drug · BLA
Sogroya (Somapacitan-beco) NDC 0169-2037
Somapacitan 10 mg/mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-2037-11 | 00169203711 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-11) / 1.5 mL in 1 SYRINGE, PLASTICMarketed from May 1, 2023 | |
| 0169-2037-90 | 00169203790 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-90) / 1.5 mL in 1 SYRINGE, PLASTICMarketed from May 1, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Sogroya
- Generic name (nonproprietary)
- somapacitan-beco
- Active ingredients
- Somapacitan — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761156
- Marketing start
- Listing expires
- Identifiers
- Product ID 0169-2037_02935ecf-5395-4b9b-9b2f-75d59ca651f3SPL ID 02935ecf-5395-4b9b-9b2f-75d59ca651f3SPL set ID eadd03b4-adc3-4b88-8a24-9d205c5b85aaRxCUI 2557398, 2557403, 2571802, 2571805, 2636951, 2636954UNII 8FOJ430U94
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
N400169203711followed by a unit qualifier and the quantityPackage 00169-2037-11. 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)
SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age. • Growth failure associated with Noonan syndrome (NS). • Idiopathic Short Stature (ISS). SOGROYA is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). ( 1 ) • Short …
Excerpt only. Read the full label for complete information.
About NDC 0169-2037
- What is NDC 0169-2037?
- 0169-2037 is the product NDC for Sogroya (somapacitan-beco), Somapacitan 10 mg/mL injection, solution, listed with the FDA by Novo Nordisk. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sogroya (Somapacitan-beco).
- What is the active ingredient?
- Somapacitan.
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sogroya?
- 2 other product NDCs are listed under this name. See all Sogroya NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sogroya products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sogroyasomapacitan-beco | Somapacitan 6.7 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2030 | 00169-2030-1100169-2030-90 |
| Sogroyasomapacitan-beco | Somapacitan 3.3 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2035 | 00169-2035-1100169-2035-90 |
Other NDCs under BLA 761156
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 |
|---|---|---|---|---|
| Sogroyasomapacitan-beco | Somapacitan 6.7 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2030 |
| Sogroyasomapacitan-beco | Somapacitan 3.3 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2035 |