DrugDashboards

Baclofen

Baclofen · BACLOFEN 500 ug/mL · Injection · Intrathecal · Advagen Pharma Limited

NDC 72888-0145-36 · 1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Immacule Lifesciences Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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.

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 · avg $17.27 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA217324
TE code
AP
Approval date
Feb 22, 2023
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 Baclofen (Injection)

LabelerStrengthFirst seenLast seen
Advagen Pharma LimitedBACLOFEN 1000 ug/mLJul 15, 2026Sep 2, 2026
Advagen Pharma LimitedBACLOFEN 500 ug/mLJul 15, 2026Sep 2, 2026
Advagen Pharma LimitedBACLOFEN 2000 ug/mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCBACLOFEN .05 mg/mLJul 15, 2026Sep 2, 2026
MAIA Pharmaceuticals, Inc.BACLOFEN 500 ug/mLJul 15, 2026Sep 2, 2026
MAIA Pharmaceuticals, Inc.BACLOFEN 2000 ug/mLJul 15, 2026Sep 2, 2026
MAlA Pharmaceuticals, Inc.BACLOFEN 50 ug/mLJul 15, 2026Sep 2, 2026
MAlA Pharmaceuticals, Inc.BACLOFEN 1000 ug/mLJul 15, 2026Sep 2, 2026
Nexus Pharmaceuticals LLCBACLOFEN 2000 ug/mLJul 15, 2026Sep 2, 2026
Sintetica S.A.BACLOFEN 40 mg/20mLJul 15, 2026Sep 2, 2026
Sintetica S.A.BACLOFEN 10 mg/5mLJul 15, 2026Sep 2, 2026
Sintetica S.A.BACLOFEN .05 mg/mLJul 15, 2026Sep 2, 2026
Sintetica S.A.BACLOFEN 10 mg/20mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Baclofen — NDC 72888-0145-36," retrieved September 3, 2026, https://drugdashboards.com/drug/72888014536.

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