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emtricitabine, rilpivirine and tenofovir disoproxil fumarate

emtricitabine, rilpivirine and tenofovir disoproxil fumarate · EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 · Tablet, Film Coated · Oral · Laurus Labs Limited

NDC 42385-0801-30 · 30 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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

$0$50.00$100.00$150.00Jun 2026Sep 2026$114.50
4 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$3435.09
#90 count
$10305.27

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for emtricitabine, rilpivirine and tenofovir disoproxil fumarate (oral solid) in the next 90 days

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
ANDA220232
TE code
AB
Approval date
Mar 4, 2026
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 emtricitabine, rilpivirine and tenofovir disoproxil fumarate (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Laurus Labs LimitedEMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "emtricitabine, rilpivirine and tenofovir disoproxil fumarate — NDC 42385-0801-30," retrieved September 3, 2026, https://drugdashboards.com/drug/42385080130.

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