Baclofen
Baclofen · BACLOFEN 10 mg/20mL · Injection · Sintetica S.A.
NDC 68055-0003-20 · 840 PACKAGE in 1 CASE / 20 AMPULE in 1 PACKAGE / 20 mL in 1 AMPULE · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.
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.
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
- —
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- —
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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Advagen Pharma Limited | BACLOFEN 1000 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| Advagen Pharma Limited | BACLOFEN 500 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| Advagen Pharma Limited | BACLOFEN 2000 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | BACLOFEN .05 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| MAIA Pharmaceuticals, Inc. | BACLOFEN 500 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| MAIA Pharmaceuticals, Inc. | BACLOFEN 2000 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| MAlA Pharmaceuticals, Inc. | BACLOFEN 50 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| MAlA Pharmaceuticals, Inc. | BACLOFEN 1000 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| Nexus Pharmaceuticals LLC | BACLOFEN 2000 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sintetica S.A. | BACLOFEN 40 mg/20mL | Jul 15, 2026 | Sep 2, 2026 |
| Sintetica S.A. | BACLOFEN 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Sintetica S.A. | BACLOFEN .05 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sintetica S.A. | BACLOFEN 10 mg/20mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Baclofen — NDC 68055-0003-20," retrieved September 3, 2026, https://drugdashboards.com/drug/68055000320.
Free to cite with attribution — see how the data is put together.