NDC 42367-540

RYANODEX dantrolene sodium

Dantrolene Sodium

RYANODEX dantrolene sodium is a Intravenous Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Eagle Pharmaceuticals, Inc.. The primary component is Dantrolene Sodium.

• Product ID: 42367-540_651d74ad-433d-4ac8-a7cd-7d79460b08ac
• NDC: 42367-540
• Product Type: Human Prescription Drug
• Proprietary Name: RYANODEX dantrolene sodium
• Generic Name: Dantrolene Sodium
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-07-23
• Marketing Category: NDA / NDA
• Application Number: NDA205579
• Labeler Name: Eagle Pharmaceuticals, Inc.
• Substance Name: DANTROLENE SODIUM
• Active Ingredient Strength: 250 mg/5mL
• Pharm Classes: Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 42367-540-32

1 VIAL in 1 CARTON (42367-540-32) > 20 mL in 1 VIAL

• Marketing Start Date: 2014-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42367-540-32 [42367054032]

RYANODEX dantrolene sodium INJECTION, SUSPENSION

• Marketing Category: NDA
• Application Number: NDA205579
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-23

Drug Details

Active Ingredients

Ingredient	Strength
DANTROLENE SODIUM	250 mg/5mL

OpenFDA Data

• SPL SET ID: 8f7b3ac0-604d-4c78-b545-5e0f8ea3d698
• Manufacturer:
  • Eagle Pharmaceuticals, Inc.
• UNII:
  • 287M0347EV
• RxNorm Concept Unique ID - RxCUI:
  • 1544758
  • 1544753
• UPC Code:
  • 0342367540325

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]

NDC Crossover Matching brand name "RYANODEX dantrolene sodium" or generic name "Dantrolene Sodium"

NDC	Brand Name	Generic Name
42023-123	Dantrium	dantrolene sodium
42023-124	Dantrium	dantrolene sodium
42023-125	Dantrium	dantrolene sodium
0115-4411	Dantrolene Sodium	Dantrolene Sodium
0115-4422	Dantrolene Sodium	Dantrolene Sodium
0115-4433	Dantrolene Sodium	Dantrolene Sodium
0527-3219	Dantrolene Sodium	dantrolene sodium
0527-3220	Dantrolene Sodium	dantrolene sodium
0527-3221	Dantrolene Sodium	dantrolene sodium
0904-7211	Dantrolene Sodium	Dantrolene Sodium
42023-144	dantrolene sodium	dantrolene sodium
49884-362	dantrolene sodium	dantrolene sodium
49884-363	dantrolene sodium	dantrolene sodium
49884-364	dantrolene sodium	dantrolene sodium
50268-217	Dantrolene Sodium	Dantrolene Sodium
55154-7140	Dantrolene Sodium	Dantrolene Sodium
63629-2168	dantrolene sodium	dantrolene sodium
63629-2169	dantrolene sodium	dantrolene sodium
63629-2170	dantrolene sodium	dantrolene sodium
64850-840	Dantrolene Sodium	dantrolene sodium
64850-841	Dantrolene Sodium	dantrolene sodium
64850-842	Dantrolene Sodium	dantrolene sodium
68084-300	Dantrolene Sodium	Dantrolene Sodium
27505-003	Revonto	dantrolene sodium
42367-540	RYANODEX	dantrolene sodium