NDC 0115-4433

Dantrolene Sodium

Dantrolene Sodium

Dantrolene Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Dantrolene Sodium.

• Product ID: 0115-4433_136adc42-ef12-4bc7-849c-89cca8629012
• NDC: 0115-4433
• Product Type: Human Prescription Drug
• Proprietary Name: Dantrolene Sodium
• Generic Name: Dantrolene Sodium
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2005-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076856
• Labeler Name: Impax Generics
• Substance Name: DANTROLENE SODIUM
• Active Ingredient Strength: 100 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: 2019-12-31

Packaging

NDC 0115-4433-01

100 CAPSULE in 1 BOTTLE (0115-4433-01)

• Marketing Start Date: 2005-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0115-4433-02 [00115443302]

Dantrolene Sodium CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA076856
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-03-01

NDC 0115-4433-01 [00115443301]

Dantrolene Sodium CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA076856
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-03-01

NDC 0115-4433-03 [00115443303]

Dantrolene Sodium CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA076856
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-03-01

Drug Details

Active Ingredients

Ingredient	Strength
DANTROLENE SODIUM	100 mg/1

OpenFDA Data

• SPL SET ID: c3c45b27-f786-456e-95d6-2e38ef36190a
• Manufacturer:
  • Impax Generics
• UNII:
  • 287M0347EV
• RxNorm Concept Unique ID - RxCUI:
  • 856652
  • 856660
  • 856656
• UPC Code:
  • 0301154411019
  • 0301154433011
  • 0301154422015

Pharmacological Class

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

NDC Crossover Matching brand name "Dantrolene Sodium" or generic name "Dantrolene Sodium"

NDC	Brand Name	Generic Name
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
68151-1520	Dantrolene Sodium	Dantrolene Sodium
42023-123	Dantrium	dantrolene sodium
42023-124	Dantrium	dantrolene sodium
42023-125	Dantrium	dantrolene sodium
27505-003	Revonto	dantrolene sodium
42367-540	RYANODEX	dantrolene sodium