0173-0832 NDC - HORIZANT (GABAPENTIN ENACARBIL)

Drug Information

Product NDC: 0173-0832

Proprietary Name: HORIZANT

Non Proprietary Name: gabapentin enacarbil

Active Ingredient(s):
  • 300 mg/1 GABAPENTIN ENACARBIL


Administration Route(s): ORAL

Dosage Form(s): TABLET, EXTENDED RELEASE

Pharmacy Class(es):
  • Anti-epileptic Agent [EPC];
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]

Labeler Information

Labeler Name: GlaxoSmithKline LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022399
Marketing Category: NDA
Start Marketing Date:12/15/2011

Package Information

No. Package Code Package Description
1 0173-0832-13 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0173-0832-13)

NDC Record

No. Field Name Field Value
1 PRODUCT NDC 0173-0832
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG
3 PROPRIETARY NAME HORIZANT
4 NON PROPRIETARY NAME gabapentin enacarbil
5 DOSAGE FORM NAME TABLET, EXTENDED RELEASE
6 ROUTE NAME ORAL
7 START MARKETING DATE 12/15/2011
8 MARKETING CATEGORY NAME NDA
9 APPLICATION NUMBER NDA022399
10 LABELER NAME GlaxoSmithKline LLC
11 SUBSTANCE NAME GABAPENTIN ENACARBIL
12 ACTIVE NUMERATOR STRENGTH 300
13 ACTIVE INGRED UNIT mg/1
14 PHARM CLASSES Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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This page was last updated on: 11/25/2014