DrugDashboards

Tramadol Hydrochloride

Tramadol Hydrochloride · TRAMADOL HYDROCHLORIDE 100 mg/1 · Tablet, Coated · Oral · Coupler LLC

NDC 67046-1541-03 · 30 TABLET, COATED in 1 BLISTER PACK · ANDA · View full market →

The short version

20 companies supply this market — deep enough that no single failure threatens the supply.

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 72888-0008-01) — 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ⓘ
$1.15per unit
middle half $0.9383–$1.34 · 169 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $1.15
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
3%of plans cover it
tier 2 · prior auth 7% · step therapy 0% · qty limit 87%

*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 2 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
ANDA208708
TE code
AB
Approval date
Jun 28, 2019
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, Coated)

LabelerStrengthFirst seenLast seen
Proficient Rx LPTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Remedyrepack Inc.TRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Advagen Pharma LimitedTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Advagen Pharma LimitedTRAMADOL HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Advagen Pharma LimitedTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Advagen Pharma LimitedTRAMADOL HYDROCHLORIDE 75 mg/1Jul 15, 2026Sep 2, 2026
Advanced Rx of Tennessee, LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.TRAMADOL HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.TRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.TRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Clinical Solutions Wholesale, LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
DirectRxTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.TRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.TRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Quality Care Products, LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
RedPharm Drug IncTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Trupharma LlcTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Trupharma LlcTRAMADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Advanced Rx Pharmacy of Tennessee, LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Aug 31, 2026
Amneal Pharmaceuticals NY LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Aug 31, 2026
Northwind Health Company, LLCTRAMADOL HYDROCHLORIDE 50 mg/1Jul 31, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Tramadol Hydrochloride — NDC 67046-1541-03," retrieved September 3, 2026, https://drugdashboards.com/drug/67046154103.

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