NDC 0591-3851

Vigabatrin

Vigabatrin

Vigabatrin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Vigabatrin.

• Product ID: 0591-3851_17b65b6f-768e-4d65-b487-6b96a1cc16af
• NDC: 0591-3851
• Product Type: Human Prescription Drug
• Proprietary Name: Vigabatrin
• Generic Name: Vigabatrin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209822
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: VIGABATRIN
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0591-3851-01

100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01)

• Marketing Start Date: 2019-02-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3851-01 [00591385101]

Vigabatrin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209822
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-02-06

Drug Details

Active Ingredients

Ingredient	Strength
VIGABATRIN	500 mg/1

OpenFDA Data

• SPL SET ID: 8dc7bd15-2636-4d58-b651-dd117ca43dbd
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • GR120KRT6K
• RxNorm Concept Unique ID - RxCUI:
  • 199521
• UPC Code:
  • 0305913851016

Pharmacological Class

• Anti-epileptic Agent [EPC]

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

NDC	Brand Name	Generic Name
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
69238-1425	Vigabatrin	Vigabatrin
69097-964	VIGABATRIN	VIGABATRIN
67877-674	VIGABATRIN	VIGABATRIN
67386-111	SABRIL	vigabatrin
67386-211	SABRIL	vigabatrin
31722-009	vigabatrin for oral solution	vigabatrin
0054-0702	Vigabatrin for oral solution USP, 500 mg	Vigabatrin
0245-0556	VIGADRONE	vigabatrin