Prescription medicine
Octreotide Brand names: Sandostatin, Mycapssa, Bynfezia
Octreotide (Sandostatin) is a prescription medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $2.53 per mL (Octreotide acet 100 mcg/mL vial) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $3,523.03 per unit (Sandostatin lar depot 10 mg kt).
- Generic listed
Check it at the source: the octreotide FDA label on DailyMed (effective July 22, 2026, Novartis Pharmaceuticals Corporation); the NDA 19667 record on Drugs@FDA; every octreotide label on DailyMed.
Highlights of the record
FDA label of July 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSandostatin Injection is a somatostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1;
Forms and strengths
- 20 mg
- 2.5 mg/ml
Injection (solution); kit; delayed-release capsule; injection.
On the market
- Earliest approval on file
- October 21, 1988 Sandostatin, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first March 28, 2005; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 9 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- December 29, 2041 Bynfezia Pen injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.53 per mL Octreotide acet 100 mcg/mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 11 since 2012 1 Class I among all firms' recalls; latest April 24, 2026
- FAERS reports
- 30,742 through July 30, 2026
What is octreotide used for?
From the label: indications and usageSandostatin Injection is a somatostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. […]
Conditions named in the indications of octreotide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Somatostatin Analog.
Source: FDA drug label (Sandostatin), Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set 4e2c9856-1836-49f0-9472-4dbeeb408f39), via openFDA; the full label on DailyMed
Is there a generic for octreotide (Sandostatin)?
The FDA approved the first generic octreotide on March 28, 2005. 23 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists octreotide from 9 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Sandostatin injection; a patent listed only for Bynfezia Pen injection runs to December 29, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1988 earliest approval on file
- 2005 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for octreotide (Sandostatin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.53 per mL (Octreotide acet 100 mcg/mL vial), down 9% from $2.80 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Octreotide acet 100 mcg/mL vial (generic)
- Sandostatin lar depot 10 mg kt (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Octreotide 1,000 mcg/5 mL vial | Generic | $5.34 per mL | $26.70 per vial | +2% |
| Octreotide acet 100 mcg/mL syringe | Generic | $5.24 per mL | n/a | n/a |
| Octreotide acet 100 mcg/mL vial | Generic | $2.53 per mL | n/a | -9% |
| Octreotide acet 50 mcg/mL vial | Generic | $2.64 per mL | n/a | +0.8% |
| Sandostatin lar depot 10 mg kt | Brand | $3,523.03 per unit | n/a | n/a |
| Sandostatin lar depot 20 mg kt | Brand | $4,588.55 per unit | n/a | +3% |
| Sandostatin lar depot 30 mg kt | Brand | $6,948.08 per unit | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has octreotide been recalled?
The FDA's Enforcement Report lists 11 recalls naming octreotide since 2012: 1 Class I (the most serious), 10 Class II, 0 Class III; 4 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 24, 2026 | Class II | Teva Pharmaceuticals USA, Inc | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract … |
| March 17, 2026 | Class II | Teva Pharmaceuticals USA, Inc | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract … |
| October 7, 2022 | Class I | Viatris Inc | Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. |
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| May 4, 2016 | Class II | Fresenius Kabi USA, LLC | Failed Impuities/Degradation Specifications |
| May 1, 2012 | Class II | Ben Venue Laboratories Inc | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the octreotide label say about other medicines?
The octreotide label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name octreotide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetic acid | warnings and precautions | Growth Hormone, IGF-1 (somatomedin C) Carcinoid: HIAA (urinary 5-hydroxyindole acetic acid), plasma serotonin, plasma Substance P VIPoma: |
| Bromocriptine | drug interactions | Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine. |
| Cyclosporine | drug interactions | Concomitant administration of Sandostatin Injection with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection. |
| Digoxin | drug interactions | Digoxin: exposure may be decreased and assessment of clinical response to digoxin should be performed ( 7 ). |
| Esomeprazole | drug interactions | Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids Clinical Impact: Concomitant administration of MYCAPSSA with esomeprazole resulted in a decrease in the bioavailability for MYCAPSSA [ See ]. Drugs that alter the pH of the upper GI tract (…) may alter the absorption of MYCAPSSA and lead to a reduction in … Intervention: Co-administration of MYCAPSSA with PPIs, H2-blockers, or antacids may require increased doses of MYCAPSSA. |
| Glucagon | drug interactions | Octreotide inhibits the secretion of insulin and glucagon. |
| Levonorgestrel | drug interactions | Levonorgestrel Clinical Impact: Concomitant administration of MYCAPSSA with levonorgestrel decreases levonorgestrel bioavailability. Intervention: Decreased bioavailability may potentially diminish the effectiveness of combined oral contraceptives (COCs) or increase breakthrough bleeding. … |
| Lisinopril | drug interactions | Lisinopril: bioavailability may be increased, monitor patient's blood pressure and adjust dose of lisinopril if needed ( 7 ). |
| Quinidine | drug interactions | Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution. |
Other labels that name octreotide
Source: FDA drug label (Sandostatin), Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set 4e2c9856-1836-49f0-9472-4dbeeb408f39), via openFDA; the full label on DailyMed
What do FAERS reports show for octreotide?
The FDA Adverse Event Reporting System holds 30,742 reports that list octreotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,112 are coded as a death and 10,420 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other somatostatin analogs
- the pharmacologic class, with prices and generics
- Octreotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other