NDC 55292-602

Peganone

Ethotoin

Peganone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Ethotoin.

• Product ID: 55292-602_5047477f-e443-4681-8716-e0d0b9a61cbc
• NDC: 55292-602
• Product Type: Human Prescription Drug
• Proprietary Name: Peganone
• Generic Name: Ethotoin
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1957-04-22
• Marketing Category: NDA / NDA
• Application Number: NDA010841
• Labeler Name: RECORDATI RARE DISEASES, INC.
• Substance Name: ETHOTOIN
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55292-602-01

100 TABLET in 1 BOTTLE (55292-602-01)

• Marketing Start Date: 1957-04-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55292-602-01 [55292060201]

Peganone TABLET

• Marketing Category: NDA
• Application Number: NDA010841
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1957-04-22

Drug Details

Active Ingredients

Ingredient	Strength
ETHOTOIN	250 mg/1

OpenFDA Data

• SPL SET ID: afcb9d60-3668-3890-5fed-f0794a12509d
• Manufacturer:
  • RECORDATI RARE DISEASES, INC.
• UNII:
  • 46QG38NC4U
• RxNorm Concept Unique ID - RxCUI:
  • 197683
  • 206750
• UPC Code:
  • 0355292602013
  • 0367386601017

Pharmacological Class

• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]