DrugDashboards

Hydrocodone Bitartrate and Ibuprofen

Hydrocodone Bitartrate and Ibuprofen · HYDROCODONE BITARTRATE 7.5 mg/1; IBUPROFEN 200 mg/1 · Tablet, Film Coated · Oral · Aurolife Pharma, LLC

NDC 13107-0004-05 · 500 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.

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)

0.1%chance of a new FDA shortage posting for hydrocodone bitartrate and ibuprofen (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 →

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
ANDA204575
TE code
AB
Approval date
Jun 2, 2016
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 Hydrocodone Bitartrate and Ibuprofen (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 7.5 mg/1; IBUPROFEN 200 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Hydrocodone Bitartrate and Ibuprofen — NDC 13107-0004-05," retrieved September 3, 2026, https://drugdashboards.com/drug/13107000405.

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