NDC 58281-561

Lioresal

Baclofen

Lioresal is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Medtronic Neuromodulation. The primary component is Baclofen.

• Product ID: 58281-561_824b1807-be48-4239-bfdc-2d1d15b42c71
• NDC: 58281-561
• Product Type: Human Prescription Drug
• Proprietary Name: Lioresal
• Generic Name: Baclofen
• Dosage Form: Injection
• Route of Administration: INTRATHECAL
• Marketing Start Date: 1992-06-17
• Marketing Category: NDA / NDA
• Application Number: NDA020075
• Labeler Name: Medtronic Neuromodulation
• Substance Name: BACLOFEN
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 58281-561-02

2 AMPULE in 1 PACKAGE, COMBINATION (58281-561-02) > 5 mL in 1 AMPULE

• Marketing Start Date: 1992-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58281-561-02 [58281056102]

Lioresal INJECTION

• Marketing Category: NDA
• Application Number: NDA020075
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1992-06-17
• Inactivation Date: 2020-01-31

NDC 58281-561-08 [58281056108]

Lioresal INJECTION

• Marketing Category: NDA
• Application Number: NDA020075
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-06-17
• Marketing End Date: 2013-03-21

NDC 58281-561-04 [58281056104]

Lioresal INJECTION

• Marketing Category: NDA
• Application Number: NDA020075
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-06-17
• Marketing End Date: 2013-03-21

Drug Details

Active Ingredients

Ingredient	Strength
BACLOFEN	2 mg/mL

OpenFDA Data

• SPL SET ID: 351cde63-00fa-404a-92df-cb055e991840
• Manufacturer:
  • Medtronic Neuromodulation
• UNII:
  • H789N3FKE8
• RxNorm Concept Unique ID - RxCUI:
  • 805678
  • 805679
  • 1666620
  • 1666622
  • 1666623
  • 1666613
  • 308517
  • 308516

Pharmacological Class

• GABA A Agonists [MoA]
• GABA B Agonists [MoA]
• gamma-Aminobutyric Acid-ergic Agonist [EPC]

NDC Crossover Matching brand name "Lioresal" or generic name "Baclofen"

NDC	Brand Name	Generic Name
58281-560	Lioresal	Lioresal
58281-562	Lioresal	Lioresal
58281-563	Lioresal	Lioresal
58281-561	Lioresal	Lioresal
0115-1010	Baclofen	Baclofen
0115-1011	Baclofen	Baclofen
0115-1012	Baclofen	Baclofen
0172-4096	Baclofen	Baclofen
0172-4097	Baclofen	Baclofen
0527-1330	Baclofen	baclofen
0527-1333	Baclofen	baclofen
0527-1337	Baclofen	baclofen
0603-2406	Baclofen	Baclofen
0603-2407	Baclofen	Baclofen
0615-3541	Baclofen	Baclofen
0615-3542	Baclofen	Baclofen
0615-8411	Baclofen	Baclofen
0615-8412	Baclofen	Baclofen