The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Tramadol Hydrochloride
Tramadol Hydrochloride · TRAMADOL HYDROCHLORIDE 100 mg/1 · Tablet, Film Coated, Extended Release · Oral · Proficient Rx LP
NDC 82804-0298-30 · 30 TABLET, FILM COATED, EXTENDED RELEASE 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)
0.2%chance of a new FDA shortage posting for tramadol hydrochloride (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months
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
- ANDA209404
- TE code
- AB1
- Approval date
- Jan 31, 2025
- 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 Tramadol Hydrochloride (Tablet, Film Coated, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | TRAMADOL HYDROCHLORIDE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | TRAMADOL HYDROCHLORIDE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | TRAMADOL HYDROCHLORIDE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | TRAMADOL HYDROCHLORIDE 100 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, "Tramadol Hydrochloride — NDC 82804-0298-30," retrieved September 3, 2026, https://drugdashboards.com/drug/82804029830.
Free to cite with attribution — see how the data is put together.