NDC 0245-0556

VIGADRONE

Vigabatrin

VIGADRONE is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Vigabatrin.

• Product ID: 0245-0556_262f56f4-e7ec-4f9b-b7d3-cd252e59407b
• NDC: 0245-0556
• Product Type: Human Prescription Drug
• Proprietary Name: VIGADRONE
• Generic Name: Vigabatrin
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210196
• Labeler Name: Upsher-Smith Laboratories, LLC
• Substance Name: VIGABATRIN
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Anti-epileptic Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0245-0556-50

50 PACKET in 1 CARTON (0245-0556-50) > 10 mL in 1 PACKET (0245-0556-89)

• Marketing Start Date: 2018-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0245-0556-89 [00245055689]

VIGADRONE POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-21

NDC 0245-0556-50 [00245055650]

VIGADRONE POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-21

Drug Details

Active Ingredients

Ingredient	Strength
VIGABATRIN	50 mg/mL

OpenFDA Data

• SPL SET ID: 5e5e7554-d0f4-47f7-a434-cc5ca5a9826f
• Manufacturer:
  • Upsher-Smith Laboratories, LLC
• UNII:
  • GR120KRT6K
• RxNorm Concept Unique ID - RxCUI:
  • 2047868
  • 250820

Pharmacological Class

• Anti-epileptic Agent [EPC]

NDC Crossover Matching brand name "VIGADRONE" or generic name "Vigabatrin"

NDC	Brand Name	Generic Name
0245-0556	VIGADRONE	vigabatrin
67386-111	SABRIL	vigabatrin
67386-211	SABRIL	vigabatrin
0054-0652	Vigabatrin	Vigabatrin
0574-0201	VIGABATRIN	vigabatrin
0574-0470	VIGABATRIN	vigabatrin
0591-3851	Vigabatrin	Vigabatrin
0591-3955	vigabatrin	vigabatrin
16729-521	Vigabatrin	Vigabatrin
42799-950	Vigabatrin	Vigabatrin
43598-651	Vigabatrin	Vigabatrin
43598-697	Vigabatrin	Vigabatrin
49884-358	VIGABATRIN	vigabatrin
59651-366	Vigabatrin	Vigabatrin
59651-367	Vigabatrin	Vigabatrin
64850-940	Vigabatrin	vigabatrin
31722-009	vigabatrin for oral solution	vigabatrin
0054-0702	Vigabatrin for oral solution USP, 500 mg	Vigabatrin