DrugDashboards

Apadaz

Benzhydrocodone and Acetaminophen · BENZHYDROCODONE HYDROCHLORIDE 4.08 mg/1; ACETAMINOPHEN 325 mg/1 · Tablet · Oral · Zevra Therapeutics, Inc.

NDC 70040-0145-01 · 100 TABLET in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Kvk-Tech, Inc., 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.

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
NDA208653
TE code
Approval date
Feb 23, 2018
Patents / exclusivity
15 patents, 0 exclusivities
TypeNumber / codeExpires
patent8461137Feb 22, 2031
patent8461137Feb 22, 2031
patent8461137Feb 22, 2031
patent9549923Jul 1, 2030
patent8828978Jul 1, 2030
patent9549923Jul 1, 2030
patent8828978Jul 1, 2030
patent9132125Jul 1, 2030
patent8828978Jul 1, 2030
patent9549923Jul 1, 2030
patent8748413Jul 1, 2030
patent8748413Jul 1, 2030

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Benzhydrocodone and Acetaminophen (Tablet)

LabelerStrengthFirst seenLast seen
Zevra Therapeutics, Inc.BENZHYDROCODONE HYDROCHLORIDE 8.16 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Zevra Therapeutics, Inc.BENZHYDROCODONE HYDROCHLORIDE 4.08 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Zevra Therapeutics, Inc.BENZHYDROCODONE HYDROCHLORIDE 6.12 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Zevra Therapeutics, Inc.BENZHYDROCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 6.12 mg/1Jul 22, 2026Aug 19, 2026
Zevra Therapeutics, Inc.BENZHYDROCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 4.08 mg/1Jul 22, 2026Aug 19, 2026
Zevra Therapeutics, Inc.BENZHYDROCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 8.16 mg/1Jul 22, 2026Aug 19, 2026
Zevra Therapeutics, Inc.ACETAMINOPHEN 325 mg/1; BENZHYDROCODONE HYDROCHLORIDE 4.08 mg/1Jul 15, 2026Jul 15, 2026
Zevra Therapeutics, Inc.ACETAMINOPHEN 325 mg/1; BENZHYDROCODONE HYDROCHLORIDE 8.16 mg/1Jul 15, 2026Jul 15, 2026
Zevra Therapeutics, Inc.ACETAMINOPHEN 325 mg/1; BENZHYDROCODONE HYDROCHLORIDE 6.12 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Apadaz — NDC 70040-0145-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70040014501.

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