DrugDashboards

Duloxetine Delayed-Release

Duloxetine Hydrochloride · DULOXETINE HYDROCHLORIDE 30 mg/1 · Capsule, Delayed Release Pellets · Oral · Breckenridge Pharmaceutical, Inc.

NDC 51991-0747-10 · 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE · ANDA · View full market →

The short version

13 companies supply this market — deep enough that no single failure threatens the supply. The price has jumped 37% in a year, to $0.1058 per unit — sharp rises like this often mean supply is already tightening. 5 Class II recalls hit this product in the past year (Breckenridge Pharmaceutical, Inc.). 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 0.2% of the time — roughly 2× 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)$0.1058per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicaid generic ceiling (FUL)$0.1058per CAPweighted avg manufacturer price $0.0508 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$2.00$4.00$6.00Jul 2014Sep 2026$0.1058
147 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$3.18
#90 count
$9.53

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$1.3M
97,698 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

15● Low risk

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

  • Class I/II recall in past 12 months+15

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)

0.2%chance of a new FDA shortage posting for duloxetine hydrochloride (oral solid) in the next 90 days

6 Class I/II recall(s) in 12 months · price up 12% YoY · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 2× 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 →

Regulatory

Application
ANDA203088
TE code
AB
Approval date
Jun 11, 2014
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJun 4, 2026
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · OngoingJun 4, 2026
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · OngoingApr 21, 2026
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
  • Class II · OngoingNov 24, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
  • Class II · OngoingOct 9, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
  • Class II · OngoingJul 15, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
  • Class II · OngoingJun 30, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · OngoingApr 14, 2025
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
  • Class II · OngoingApr 14, 2025
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
  • Class II · OngoingMar 26, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
  • Class II · OngoingFeb 28, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Class II · OngoingFeb 28, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Class II · OngoingFeb 28, 2025
    Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Class II · OngoingDec 6, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Class II · OngoingDec 6, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Class II · CompletedOct 10, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · TerminatedMay 17, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · OngoingApr 29, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · OngoingApr 29, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Class II · OngoingApr 29, 2024
    Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Manufacturers of Duloxetine Hydrochloride (Capsule, Delayed Release Pellets)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackDULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsDULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsDULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Aphena Pharma Solutions - Tennessee, LLCDULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Aphena Pharma Solutions - Tennessee, LLCDULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesDULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Breckenridge Pharmaceutical, Inc.DULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Breckenridge Pharmaceutical, Inc.DULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Breckenridge Pharmaceutical, Inc.DULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Breckenridge Pharmaceutical, Inc.DULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.DULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.DULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.DULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.DULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.DULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.DULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPDULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPDULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPDULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPDULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health, LLCDULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health, LLCDULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health, LLCDULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health, LLCDULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.DULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Towa Pharmaceutical Europe, S.L.DULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Towa Pharmaceutical Europe, S.L.DULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Towa Pharmaceutical Europe, S.L.DULOXETINE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Towa Pharmaceutical Europe, S.L.DULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Yaopharma Co., Ltd.DULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Yaopharma Co., Ltd.DULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Yaopharma Co., Ltd.DULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackDULOXETINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Aug 31, 2026
Bryant Ranch PrepackDULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Aug 31, 2026
Bryant Ranch PrepackDULOXETINE HYDROCHLORIDE 20 mg/1Jul 15, 2026Aug 31, 2026
Aphena Pharma Solutions - Tennessee, LLCDULOXETINE HYDROCHLORIDE 30 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Duloxetine Delayed-Release — NDC 51991-0747-10," retrieved September 3, 2026, https://drugdashboards.com/drug/51991074710.

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