NDC 43598-697

Vigabatrin

Vigabatrin

Vigabatrin is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy. The primary component is Vigabatrin.

Product ID43598-697_33e72db8-0d37-5162-cd20-812948f65a65
NDC43598-697
Product TypeHuman Prescription Drug
Proprietary NameVigabatrin
Generic NameVigabatrin
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2018-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA211481
Labeler NameDr. Reddy
Substance NameVIGABATRIN
Active Ingredient Strength50 mg/mL
Pharm ClassesAnti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43598-697-50

50 PACKET in 1 CARTON (43598-697-50) > 10 mL in 1 PACKET (43598-697-11)
Marketing Start Date2018-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-697-11 [43598069711]

Vigabatrin POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA211481
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-21

NDC 43598-697-50 [43598069750]

Vigabatrin POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA211481
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-21

Drug Details

Active Ingredients

IngredientStrength
VIGABATRIN50 mg/mL

OpenFDA Data

SPL SET ID:f6be436e-46c7-e9ab-0fcf-e8d04dc12b72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 250820
  • Pharmacological Class

    • Anti-epileptic Agent [EPC]

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

    NDCBrand NameGeneric Name
    0054-0652VigabatrinVigabatrin
    0574-0201VIGABATRINvigabatrin
    0574-0470VIGABATRINvigabatrin
    0591-3851VigabatrinVigabatrin
    0591-3955vigabatrinvigabatrin
    16729-521VigabatrinVigabatrin
    42799-950VigabatrinVigabatrin
    43598-651VigabatrinVigabatrin
    43598-697VigabatrinVigabatrin
    49884-358VIGABATRINvigabatrin
    59651-366VigabatrinVigabatrin
    59651-367VigabatrinVigabatrin
    64850-940Vigabatrinvigabatrin
    69238-1425VigabatrinVigabatrin
    69097-964VIGABATRINVIGABATRIN
    67877-674VIGABATRINVIGABATRIN
    67386-111SABRILvigabatrin
    67386-211SABRILvigabatrin
    31722-009vigabatrin for oral solutionvigabatrin
    0054-0702Vigabatrin for oral solution USP, 500 mgVigabatrin
    0245-0556VIGADRONEvigabatrin

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