horizant

Generic: gabapentin enacarbil

Labeler: azurity pharmaceuticals, inc. (formerly arbor pharmaceuticals)
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name horizant
Generic Name gabapentin enacarbil
Labeler azurity pharmaceuticals, inc. (formerly arbor pharmaceuticals)
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

gabapentin enacarbil 300 mg/1

Manufacturer
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)

Identifiers & Regulatory

Product NDC 53451-0103
Product ID 53451-0103_33da187f-72d1-daa5-e063-6394a90a66b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022399
Listing Expiration 2026-12-31
Marketing Start 2013-05-01

Pharmacologic Class

Classes
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 534510103
Hyphenated Format 53451-0103

Supplemental Identifiers

RxCUI
1101338 1101339 1482820 1482821
UNII
75OCL1SPBQ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name horizant (source: ndc)
Generic Name gabapentin enacarbil (source: ndc)
Application Number NDA022399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-1)
  • 5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9)
source: ndc

Packages (2)

53451-0103-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-1) 53451-0103-9 5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9)

Ingredients (1)

gabapentin enacarbil (300 mg/1)

Linked Drug Pages (1)

Horizant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "33da187f-72d1-daa5-e063-6394a90a66b1", "openfda": {"unii": ["75OCL1SPBQ"], "rxcui": ["1101338", "1101339", "1482820", "1482821"], "spl_set_id": ["4c486fc7-c8c4-4c6c-b30c-366dabaeaadd"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-1)", "package_ndc": "53451-0103-1", "marketing_start_date": "20130501"}, {"sample": false, "description": "5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9)", "package_ndc": "53451-0103-9", "marketing_start_date": "20130501"}], "brand_name": "Horizant", "product_id": "53451-0103_33da187f-72d1-daa5-e063-6394a90a66b1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53451-0103", "generic_name": "gabapentin enacarbil", "labeler_name": "Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Horizant", "active_ingredients": [{"name": "GABAPENTIN ENACARBIL", "strength": "300 mg/1"}], "application_number": "NDA022399", "marketing_category": "NDA", "marketing_start_date": "20130501", "listing_expiration_date": "20261231"}