DrugDashboards

Entecavir

Entecavir · ENTECAVIR .5 mg/1 · Tablet, Film Coated · Oral · Zydus Pharmaceuticals USA Inc.

NDC 68382-0920-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply. 4 Class II recalls hit this product in the past year (Zydus Pharmaceuticals (USA) Inc).

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 00003-1611-12) — 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
$46.72per unit
middle half $46.72$46.72 · 12 plans · Apr 1, 2026
Est. net of rebates
≈ $46.72
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 83% · 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)

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

4 Class I/II recall(s) in 12 months · 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 in ordinary territory.

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
ANDA206745
TE code
AB
Approval date
Jun 23, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingSep 24, 2025
    Zydus Pharmaceuticals (USA) IncFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
  • Class II · OngoingSep 24, 2025
    Zydus Pharmaceuticals (USA) IncFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
  • Class II · OngoingSep 4, 2025
    Zydus Pharmaceuticals (USA) IncFailed Impurity/Degradation Specifications
  • Class II · OngoingSep 4, 2025
    Zydus Pharmaceuticals (USA) IncFailed Impurity/Degradation Specifications

Manufacturers of Entecavir (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
AvKAREENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.ENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.ENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
E.R. Squibb & Sons, L.L.C.ENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
E.R. Squibb & Sons, L.L.C.ENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCENTECAVIR ANHYDROUS 1 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCENTECAVIR ANHYDROUS .5 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
Patheon, Inc.ENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
Patheon, Inc.ENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare LLCENTECAVIR ANHYDROUS 1 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare LLCENTECAVIR ANHYDROUS .5 mg/1Jul 15, 2026Sep 2, 2026
Yaopharma Co., Ltd.ENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
Yaopharma Co., Ltd.ENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.ENTECAVIR 1 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.ENTECAVIR .5 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Entecavir — NDC 68382-0920-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68382092001.

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