NDC 50742-232

DOFETILIDE

Dofetilide

DOFETILIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Dofetilide.

Product ID50742-232_48d0f98b-6823-4b23-9925-90008748feeb
NDC50742-232
Product TypeHuman Prescription Drug
Proprietary NameDOFETILIDE
Generic NameDofetilide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA212410
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameDOFETILIDE
Active Ingredient Strength1 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50742-232-60

60 CAPSULE in 1 BOTTLE, PLASTIC (50742-232-60)
Marketing Start Date2020-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-232-60 [50742023260]

DOFETILIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA212410
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-07

Drug Details

Active Ingredients

IngredientStrength
DOFETILIDE.5 mg/1

Pharmacological Class

  • Antiarrhythmic [EPC]

NDC Crossover Matching brand name "DOFETILIDE" or generic name "Dofetilide"

NDCBrand NameGeneric Name
0904-6681DofetilideDofetilide
0904-6682DofetilideDofetilide
0904-6683DofetilideDofetilide
16714-840DofetilideDofetilide
16714-841DofetilideDofetilide
16714-842DofetilideDofetilide
16729-490DofetilideDofetilide
16729-491DofetilideDofetilide
16729-492DofetilideDofetilide
42291-411DofetilideDofetilide
42291-412DofetilideDofetilide
42291-413DofetilideDofetilide
69452-132DofetilideDofetilide
69452-133DofetilideDofetilide
69452-131DofetilideDofetilide
42794-045DofetilideDofetilide
42794-044DofetilideDofetilide
42794-046DofetilideDofetilide
47335-061DOFETILIDEDOFETILIDE
47335-062DOFETILIDEDOFETILIDE
47335-063DOFETILIDEDOFETILIDE
51862-025DofetilideDofetilide
51862-125DofetilideDofetilide
51862-005DofetilideDofetilide
59762-0037DofetilideDofetilide
59762-0038DofetilideDofetilide
59651-119DofetilideDofetilide
59651-118DofetilideDofetilide
59651-120DofetilideDofetilide
59762-0039DofetilideDofetilide
71410-301DofetilideDofetilide
71410-300DofetilideDofetilide
71410-302DofetilideDofetilide
0069-5800Tikosyndofetilide
0069-5810Tikosyndofetilide
0069-5820Tikosyndofetilide

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