Quick answers
- What is Somatropin used for?
- The FDA-approved label (Norditropin, Novo Nordisk, July 7, 2025) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Somatropin have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Somatropin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 14, 2025). Ask your pharmacist about alternatives.
- Has Somatropin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 27, 2016 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Somatropin?
- 2 companies list prescription products of Somatropin in the FDA NDC Directory, including Novo Nordisk and Sandoz Inc.
What Somatropin is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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 …
— FDA label: Norditropin, Novo Nordisk, effective July 7, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Norditropin, Omnitrope |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| somatropin 10 mg/1.5 mL injection, solution | Brand: Norditropin | $1,139.85 per mL |
| somatropin 15 mg/1.5 mL injection, solution | Brand: Norditropin | $1,708.51 per mL |
| somatropin 5 mg/1.5 mL injection, solution | Brand: Norditropin | $571.39 per mL |
| somatropin 5 mg/1.5 mL injection, solution | Brand: Omnitrope | $430.36 per mL |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novo Nordisk4 products
- Sandoz Inc2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021148 NORDITROPIN, NORDITROPIN FLEXPRO, NORDITROPIN NORDIFLEX | Novo Nordisk Inc | June 20, 2000 | 32, latest July 9, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| BLA021426 OMNITROPE | Sandoz | May 30, 2006 | 19, latest July 9, 2025 2025: Labeling · 2024: Labeling · 2024: Labeling |
Shortage status
To be discontinued · updated November 14, 2025 · first posted November 14, 2025
| Product | Norditropin, Injection, 30 mg/3 mL (NDC 0169-7703-21) |
|---|---|
| Company | Novo Nordisk, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 27, 2016 · Class II · Terminated · D-0956-2016
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 — Novo Nordisk Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Norditropin, Novo Nordisk, effective July 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →