DrugDashboards

Tramadol Hydrochloride

Tramadol Hydrochloride · TRAMADOL HYDROCHLORIDE 300 mg/1 · Tablet, Extended Release · Oral · Medsource Pharmaceuticals

NDC 45865-0184-30 · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

13 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Lupin Limited, 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

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 68180-0699-06) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$4.51per unit
middle half $3.23–$5.01 · 2,408 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $4.51
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
44%of plans cover it
tier 3 · prior auth 20% · step therapy 37% · qty limit 98%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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 →

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
ANDA200503
TE code
AB1
Approval date
Aug 29, 2011
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, Extended Release)

LabelerStrengthFirst seenLast seen
Asclemed USA, Inc.TRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 3, 2026
Asclemed USA, Inc.TRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackTRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPTRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPTRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
Sun Pharmaceutical Industries, Inc.TRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.TRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.TRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Medsource PharmaceuticalsTRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.TRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals, Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals, Inc.TRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Quality Care Products, LLCTRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Quality Care Products, LLCTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.TRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.TRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Aug 31, 2026
Sun Pharmaceutical Industries, Inc.TRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Aug 31, 2026
Sun Pharmaceutical Industries, Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Aug 31, 2026
Direct RxTRAMADOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Aug 29, 2026
Bryant Ranch PrepackTRAMADOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Tramadol Hydrochloride — NDC 45865-0184-30," retrieved September 3, 2026, https://drugdashboards.com/drug/45865018430.

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