NDC 70257-563

Lioresal (baclofen)

Baclofen

Lioresal (baclofen) is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Saol Therapeutics Inc.. The primary component is Baclofen.

• Product ID: 70257-563_2f1776d9-60a5-4b9c-83a3-6fb4b717a3cd
• NDC: 70257-563
• Product Type: Human Prescription Drug
• Proprietary Name: Lioresal (baclofen)
• Generic Name: Baclofen
• Dosage Form: Injection
• Route of Administration: INTRATHECAL
• Marketing Start Date: 2022-01-03
• Marketing Category: NDA / NDA
• Application Number: NDA020075
• Labeler Name: Saol Therapeutics Inc.
• Substance Name: BACLOFEN
• Active Ingredient Strength: 40 mg/20mL
• Pharm Classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 70257-563-01

1 AMPULE in 1 BOX (70257-563-01) > 20 mL in 1 AMPULE (70257-563-20)

• Marketing Start Date: 2022-01-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70257-563-01 [70257056301]

Lioresal (baclofen) INJECTION

• Marketing Category: NDA
• Application Number: NDA020075
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-05

NDC 70257-563-02 [70257056302]

Lioresal (baclofen) INJECTION

• Marketing Category: NDA
• Application Number: NDA020075
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-05

NDC 70257-563-20 [70257056320]

Lioresal (baclofen) INJECTION

• Marketing Category: NDA
• Application Number: NDA020075
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-05

Drug Details

Active Ingredients

Ingredient	Strength
BACLOFEN	40 mg/20mL

OpenFDA Data

• SPL SET ID: 4e478edb-e340-4976-ac24-4bb32c5e12e3
• Manufacturer:
  • Saol Therapeutics Inc.
• UNII:
  • H789N3FKE8
• RxNorm Concept Unique ID - RxCUI:
  • 805678
  • 805679
  • 1666620
  • 1666622
  • 1666623
  • 1666613
  • 308517
  • 308516
• UPC Code:
  • 0049100007533

Pharmacological Class

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

NDC Crossover Matching brand name "Lioresal (baclofen)" or generic name "Baclofen"

NDC	Brand Name	Generic Name
70257-560	Lioresal (baclofen)	Lioresal (baclofen)
70257-563	Lioresal (baclofen)	Lioresal (baclofen)
70257-562	Lioresal (baclofen)	Lioresal (baclofen)
70257-561	Lioresal (baclofen)	Lioresal (baclofen)
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