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.
Hydrocodone Bitartrate and Ibuprofen
Hydrocodone Bitartrate and Ibuprofen · HYDROCODONE BITARTRATE 2.5 mg/1; IBUPROFEN 200 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC 53746-0116-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →
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 →
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
- ANDA076642
- TE code
- AB
- Approval date
- Mar 18, 2004
- 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Amneal Pharmaceuticals of New York LLC | HYDROCODONE BITARTRATE 10 mg/1; IBUPROFEN 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals of New York LLC | HYDROCODONE BITARTRATE 2.5 mg/1; IBUPROFEN 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals of New York LLC | HYDROCODONE BITARTRATE 5 mg/1; IBUPROFEN 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals of New York LLC | HYDROCODONE BITARTRATE 7.5 mg/1; IBUPROFEN 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Hydrocodone Bitartrate and Ibuprofen — NDC 53746-0116-01," retrieved September 3, 2026, https://drugdashboards.com/drug/53746011601.
Free to cite with attribution — see how the data is put together.