Prescription drug · BLA
Norditropin (Somatropin) NDC 0169-7705
Somatropin 10 mg/1.5mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-7705-21 | 0016977052100169770521 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-21) / 1.5 mL in 1 SYRINGE, PLASTICMarketed from Mar 1, 2010 | |
| 0169-7705-92 | 0016977059200169770592 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-92) / 1.5 mL in 1 SYRINGE, PLASTICMarketed from Mar 1, 2010 |
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)
- Norditropin
- Generic name (nonproprietary)
- somatropin
- Active ingredients
- Somatropin — 10 mg/1.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021148
- Marketing start
- Listing expires
- Other FDA classes
- Human Growth Hormone (Chemical structure)
- Identifiers
- Product ID 0169-7705_b67c2419-4feb-4ce1-b97e-88760a8e1aeeSPL ID b67c2419-4feb-4ce1-b97e-88760a8e1aeeSPL set ID 1058e17c-9261-459c-a3e6-fae38d196c14RxCUI 847243, 847245, 847247, 847348, 849850, 849851, 1736262, 1736329UNII NQX9KB6PCL
- 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
N400169770521followed by a unit qualifier and the quantityPackage 00169-7705-21. 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)
NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients NORDITROPIN is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion o…
Excerpt only. Read the full label for complete information.
About NDC 0169-7705
- What is NDC 0169-7705?
- 0169-7705 is the product NDC for Norditropin (somatropin), Somatropin 10 mg/1.5mL 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?
- Norditropin (Somatropin).
- What is the active ingredient?
- Somatropin.
- 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 Norditropin?
- 3 other product NDCs are listed under this name. See all Norditropin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norditropin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Norditropinsomatropin | Somatropin 30 mg/3mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-7703 | 00169-7703-2100169-7703-92 |
| Norditropinsomatropin | Somatropin 5 mg/1.5mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-7704 | 00169-7704-2100169-7704-92 |
| Norditropinsomatropin | Somatropin 15 mg/1.5mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-7708 | 00169-7708-2100169-7708-92 |
Other NDCs under BLA 021148
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 |
|---|---|---|---|---|
| Norditropinsomatropin | Somatropin 30 mg/3mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-7703 |
| Norditropinsomatropin | Somatropin 5 mg/1.5mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-7704 |
| Norditropinsomatropin | Somatropin 15 mg/1.5mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-7708 |