DrugDashboards

Octreotide

Octreotide Acetate · OCTREOTIDE ACETATE 100 ug/mL · Injection, Solution · Intravenous; Subcutaneous · Fresenius Kabi USA, LLC

NDC 63323-0376-01 · 10 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble. The price is down 14% over the past year, to $2.41 per mL. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 4× the typical drug (0.1%).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$2.41per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$0.5960per billing unit (25 MCG)HCPCS J2354 · Jul 1, 2026
  • Part D plans paid (avg)$116.04per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$5.37per unitnegotiated price across 5,487 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$3.52per unitFresenius Kabi, LLC · May 15, 2025146% of what pharmacies pay — higher than 67% of drugs with this benchmark

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$5.37per unit
middle half $3.56$5.80 · 5,487 plans · Apr 1, 2026
Est. net of rebates
≈ $5.37
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 4 · prior auth 91% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$2.00$4.00$6.00Jun 2024Sep 2026$2.41
28 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$99.40
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 25 MCG
$0.596
HCPCS J2354 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$45,276
491 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for octreotide acetate (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 4× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 4 across plans
  • Costs ≥ $950/fill · avg $970.90 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA077457
TE code
AP
Approval date
Feb 10, 2006
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Octreotide Acetate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCOCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCOCTREOTIDE ACETATE 200 ug/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCOCTREOTIDE ACETATE 1000 ug/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedOCTREOTIDE ACETATE 1000 ug/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedOCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedOCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedOCTREOTIDE ACETATE 200 ug/mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., UsaOCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., UsaOCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Hainan Shuangcheng Pharmaceuticals Co., Ltd.OCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.OCTREOTIDE ACETATE 50 ug/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.OCTREOTIDE ACETATE 1000 ug/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.OCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.OCTREOTIDE ACETATE 200 ug/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.OCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.OCTREOTIDE ACETATE 1000 ug/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.OCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.OCTREOTIDE ACETATE 200 ug/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.OCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.OCTREOTIDE ACETATE 50 ug/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals, Inc.OCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals, Inc.OCTREOTIDE ACETATE 50 ug/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals, Inc.OCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCOCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCOCTREOTIDE ACETATE 50 ug/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCOCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationOCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationOCTREOTIDE ACETATE 50 ug/mLJul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationOCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCOCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Aug 31, 2026
Sagent PharmaceuticalsOCTREOTIDE ACETATE 1000 ug/mLJul 15, 2026Jul 29, 2026
Sagent PharmaceuticalsOCTREOTIDE ACETATE 500 ug/mLJul 15, 2026Jul 29, 2026
Sagent PharmaceuticalsOCTREOTIDE ACETATE 200 ug/mLJul 15, 2026Jul 29, 2026
Sagent PharmaceuticalsOCTREOTIDE ACETATE 100 ug/mLJul 15, 2026Jul 29, 2026
Sagent PharmaceuticalsOCTREOTIDE ACETATE 50 ug/mLJul 15, 2026Jul 29, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Octreotide — NDC 63323-0376-01," retrieved September 3, 2026, https://drugdashboards.com/drug/63323037601.

Free to cite with attribution — see how the data is put together.