DrugDashboards

Tiagabine Hydrochloride

Tiagabine Hydrochloride · TIAGABINE HYDROCHLORIDE 2 mg/1 · Tablet, Film Coated · Oral · Sun Pharmaceutical Industries, Inc.

NDC 62756-0200-18 · 1000 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Sun Pharmaceutical Industries Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. 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

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 62756-0200-83) — 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ⓘ
$3.18per unit
middle half $1.70–$4.32 · 5,631 plans · Jul 1, 2025
Est. net of rebatesⓘ
≈ $3.18
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
—of plans cover it

*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 7 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)

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

price up 23% YoY · 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 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
ANDA077555
TE code
—
Approval date
Nov 4, 2011
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Tiagabine Hydrochloride, Tablet, 12mg 30 count (NDC 0093-8072-56)Apr 15, 2026
  • Planned discontinuation — Tiagabine Hydrochloride, Tablet, 16mg 30 count (NDC 0093-8076-56)Apr 15, 2026
  • Planned discontinuation — Tiagabine Hydrochloride, Tablet, 2mg 30 count (NDC 0093-5030-56)Apr 15, 2026
  • Planned discontinuation — Tiagabine Hydrochloride, Tablet, 4mg 30 count (NDC 0093-5031-56)Apr 15, 2026

Recalls (this NDC)

  • Class II · TerminatedJul 10, 2023
    SUN PHARMACEUTICAL INDUSTRIES INC — Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Manufacturers of Tiagabine Hydrochloride (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Cephalon, LLCTIAGABINE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
Cephalon, LLCTIAGABINE HYDROCHLORIDE 4 mg/1Jul 15, 2026Sep 2, 2026
Cephalon, LLCTIAGABINE HYDROCHLORIDE 16 mg/1Jul 15, 2026Sep 2, 2026
Cephalon, LLCTIAGABINE HYDROCHLORIDE 12 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.TIAGABINE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.TIAGABINE HYDROCHLORIDE 4 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.TIAGABINE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.TIAGABINE HYDROCHLORIDE 12 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.TIAGABINE HYDROCHLORIDE 4 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.TIAGABINE HYDROCHLORIDE 16 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Tiagabine Hydrochloride — NDC 62756-0200-18," retrieved September 3, 2026, https://drugdashboards.com/drug/62756020018.

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