NDC 0527-3220

Dantrolene Sodium

Dantrolene Sodium

Dantrolene Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Dantrolene Sodium.

• Product ID: 0527-3220_aa8a58a9-7696-4c26-b277-6b4f74cd020e
• NDC: 0527-3220
• Product Type: Human Prescription Drug
• Proprietary Name: Dantrolene Sodium
• Generic Name: Dantrolene Sodium
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2005-10-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076686
• Labeler Name: Lannett Company, Inc.
• Substance Name: DANTROLENE SODIUM
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0527-3220-37

100 CAPSULE in 1 BOTTLE (0527-3220-37)

• Marketing Start Date: 2005-10-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-3220-37 [00527322037]

Dantrolene Sodium CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA076686
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-10-26

Drug Details

Active Ingredients

Ingredient	Strength
DANTROLENE SODIUM	25 mg/1

OpenFDA Data

• SPL SET ID: e23dcfd0-071a-4458-a595-3562fabccbd4
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • 287M0347EV
• UPC Code:
  • 0305273220378
  • 0305273219372
  • 0305273221375

Pharmacological Class

• Decreased Striated Muscle Contraction [PE]
• Decreased Striated Muscle Tone [PE]
• Skeletal Muscle Relaxant [EPC]
• Decreased Striated Muscle Contraction [PE]
• Decreased Striated Muscle Tone [PE]
• Skeletal Muscle Relaxant [EPC]