DrugDashboards

Entecavir

Entecavir · ENTECAVIR ANHYDROUS 1 mg/1 · Tablet, Film Coated · Oral · Solco Healthcare LLC

NDC 43547-0437-50 · 500 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. One of its named manufacturing plants, Zhejiang Huahai Pharmaceutical Co., Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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.

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
ANDA208782
TE code
—
Approval date
Oct 10, 2017
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 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 43547-0437-50," retrieved September 3, 2026, https://drugdashboards.com/drug/43547043750.

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