DrugDashboards

Duloxetine Delayed-Release

Duloxetine Hydrochloride · DULOXETINE HYDROCHLORIDE 20 mg/1 · Capsule, Delayed Release Pellets · Oral · Breckenridge Pharmaceutical, Inc.

NDC 51991-0746-06 · 60 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. 5 Class II recalls hit this product in the past year (Breckenridge Pharmaceutical, Inc.). 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.

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

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

Estimated fill cost

WAC per package, as filed
$0.00
Reported to Texas DSHS · 2024 annual filing · Breckenridge Pharmaceutical

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

Supply fragility

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

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 51991-0746-06," retrieved September 3, 2026, https://drugdashboards.com/drug/51991074606.

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