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Butalbital And Acetaminophen

butalbital and acetaminophen · ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1 · Tablet · Oral · Aarkish Pharmaceuticals NJ Inc.

NDC 81005-0123-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Aace Pharmaceuticals, Inc., 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 butalbital and acetaminophen (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 →

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
ANDA214955
TE code
AA
Approval date
Aug 16, 2022
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 butalbital and acetaminophen (Tablet)

LabelerStrengthFirst seenLast seen
Par HealthBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 27, 2026Sep 3, 2026
Aarkish Pharmaceuticals NJ Inc.ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Sep 2, 2026
Amici Pharma, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 25 mg/1Jul 15, 2026Sep 2, 2026
Amici Pharma, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Sep 2, 2026
Amici Pharma, Inc.ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
El Dorado Distributors LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Larken Laboratories, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Larken Laboratories, Inc.BUTALBITAL 25 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 31, 2026
Endo USABUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 26, 2026
Larken Laboratories, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 25 mg/1Jul 22, 2026Aug 20, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
El Dorado Distributors LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Endo USABUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Larken Laboratories, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Larken Laboratories, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 25 mg/1Jul 15, 2026Jul 19, 2026
Burel Pharmaceuticals, LLCACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Burel Pharmaceuticals, LLCACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
El Dorado Distributors LLCACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Endo USAACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Larken Laboratories, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Quagen Pharmaceuticals LlcACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Quagen Pharmaceuticals LlcACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Butalbital And Acetaminophen — NDC 81005-0123-01," retrieved September 3, 2026, https://drugdashboards.com/drug/81005012301.

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