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Valacyclovir

Valacyclovir Hydrochloride · VALACYCLOVIR HYDROCHLORIDE 1 g/1 · Tablet · Oral · Yiling Pharmaceutical, Inc.

NDC 69117-0011-02 · 90 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Yiling Pharmaceutical Ltd, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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 valacyclovir hydrochloride (oral solid) in the next 90 days

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
ANDA209553
TE code
AB
Approval date
Mar 18, 2020
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 Valacyclovir Hydrochloride (Tablet)

LabelerStrengthFirst seenLast seen
Time Cap Laboratories, Inc.VALACYCLOVIR HYDROCHLORIDE 1 g/1Jul 15, 2026Sep 2, 2026
Time Cap Laboratories, Inc.VALACYCLOVIR HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Yiling Pharmaceutical, Inc.VALACYCLOVIR HYDROCHLORIDE 1 g/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Valacyclovir — NDC 69117-0011-02," retrieved September 3, 2026, https://drugdashboards.com/drug/69117001102.

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