NDC 53451-0101

Horizant

Gabapentin Enacarbil

Horizant is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals. The primary component is Gabapentin Enacarbil.

• Product ID: 53451-0101_2f4916e7-2d50-409a-8978-2d4aaaa99291
• NDC: 53451-0101
• Product Type: Human Prescription Drug
• Proprietary Name: Horizant
• Generic Name: Gabapentin Enacarbil
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA022399
• Labeler Name: Arbor Pharmaceuticals
• Substance Name: GABAPENTIN ENACARBIL
• Active Ingredient Strength: 600 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 53451-0101-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)

• Marketing Start Date: 2013-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53451-0101-1 [53451010101]

Horizant TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-01

NDC 53451-0101-9 [53451010109]

Horizant TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022399
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-01

Drug Details

Active Ingredients

Ingredient	Strength
GABAPENTIN ENACARBIL	600 mg/1

OpenFDA Data

• SPL SET ID: 4c486fc7-c8c4-4c6c-b30c-366dabaeaadd
• Manufacturer:
  • Arbor Pharmaceuticals
• UNII:
  • 75OCL1SPBQ
• RxNorm Concept Unique ID - RxCUI:
  • 1101338
  • 1101339
  • 1482820
  • 1482821
• UPC Code:
  • 0353451010310

Pharmacological Class

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

Medicade Reported Pricing

53451010101 HORIZANT ER 600 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Horizant" or generic name "Gabapentin Enacarbil"

NDC	Brand Name	Generic Name
53451-0101	Horizant	gabapentin enacarbil
53451-0103	Horizant	gabapentin enacarbil