DrugDashboards

Octreotide Acetate

Octreotide Acetate · OCTREOTIDE ACETATE 200 ug/mL · Injection, Solution · Intravenous; Subcutaneous · Gland Pharma Limited

NDC 68083-0515-01 · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble. 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00641-6177-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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ⓘ
$8.33per unit
middle half $7.05–$12.05 · 5,490 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $8.33
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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $379.24 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA216807
TE code
AP
Approval date
Jun 13, 2023
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 Acetate — NDC 68083-0515-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083051501.

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