NDC 68418-7940

Diacomit

Stiripentol

Diacomit is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Biocodex, Inc.. The primary component is Stiripentol.

• Product ID: 68418-7940_21ec5bcf-8d8a-40a4-970a-348a1d8090c4
• NDC: 68418-7940
• Product Type: Human Prescription Drug
• Proprietary Name: Diacomit
• Generic Name: Stiripentol
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-21
• Marketing Category: NDA / NDA
• Application Number: NDA206709
• Labeler Name: BIOCODEX, INC.
• Substance Name: STIRIPENTOL
• Active Ingredient Strength: 500 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68418-7940-6

1 BOTTLE in 1 CARTON (68418-7940-6) > 60 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2018-08-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68418-7940-6 [68418794006]

Diacomit CAPSULE

• Marketing Category: NDA
• Application Number: NDA206709
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-21

NDC 68418-7940-1 [68418794001]

Diacomit CAPSULE

• Marketing Category: NDA
• Application Number: NDA206709
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-21
• Marketing End Date: 2019-03-19

Drug Details

Active Ingredients

Ingredient	Strength
STIRIPENTOL	500 mg/1

OpenFDA Data

• SPL SET ID: 58304ba8-9779-4658-811e-94ffe08c3f16
• Manufacturer:
  • BIOCODEX INC.
• UNII:
  • R02XOT8V8I
• RxNorm Concept Unique ID - RxCUI:
  • 2055014
  • 2055015
  • 2055016
  • 2054981
  • 2055011
  • 2054983
  • 2054973
  • 2054979

NDC Crossover Matching brand name "Diacomit" or generic name "Stiripentol"

NDC	Brand Name	Generic Name
68418-7939	Diacomit	stiripentol
68418-7940	Diacomit	stiripentol
68418-7941	Diacomit	stiripentol
68418-7942	Diacomit	stiripentol