FDA.reportPublic FDA data

Horizant

Product NDC
53451-0103
11-digit product format
534510103
Labeler code
53451
Product ID
53451-0103_33da187f-72d1-daa5-e063-6394a90a66b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin enacarbil
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Application
NDA022399
Marketing category
NDA
Marketing start
2013-05-01
Substance
GABAPENTIN ENACARBIL
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Horizant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN ENACARBIL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75OCL1SPBQ
Rxcui1101338, 1101339, 1482820, 1482821

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53451-0103-1Horizant30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3016
53451-0103-9Horizant5 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53451-0103-1EA - Each53451-0103a1e859b0-4431-429c-b8e7-e5013f71ab9112014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTIN ENACARBILACTIVE INGREDIENT75OCL1SPBQHORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
GABAPENTINACTIVE MOIETY6CW7F3G59XHORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UHORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53451-0103HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)]16Current NDC, Legacy NDC, 2 package rows20250507_4c486fc7-c8c4-4c6c-b30c-366dabaeaadd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482820gabapentin enacarbil 300 MG Extended Release Oral TabletPSN4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1101338gabapentin enacarbil 600 MG Extended Release Oral TabletPSN4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1482821Horizant 300 MG Extended Release Oral TabletPSN4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1101339Horizant 600 MG Extended Release Oral TabletPSN4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1482821gabapentin enacarbil 300 MG Extended Release Oral Tablet [Horizant]SBD4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1101339gabapentin enacarbil 600 MG Extended Release Oral Tablet [Horizant]SBD4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1482820gabapentin enacarbil 300 MG Extended Release Oral TabletSCD4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1101338gabapentin enacarbil 600 MG Extended Release Oral TabletSCD4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1482821Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral TabletSY4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16
1101339Horizant 600 MG Extended Release Oral TabletSY4c486fc7-c8c4-4c6c-b30c-366dabaeaadd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53451-0103-15345101030130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-1) 2013-05-010000-00-00NoNoCurrent
53451-0103-9534510103095 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9) 2013-05-010000-00-00NoNoCurrent