Horizant

Product NDC: 53451-0101
11-digit product format: 534510101
Labeler code: 53451
Product ID: 53451-0101_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: 600 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022399-001	HORIZANT	GABAPENTIN ENACARBIL	600MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2011-04-06
N022399-002	HORIZANT	GABAPENTIN ENACARBIL	300MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-12-13

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022399-001	8114909	2026-04-11	U-1231		2012-03-13
N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24
N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27
N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27
N022399-002	8114909	2026-04-11	U-1231
N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05
N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27
N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 598 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8114909	2026-04-11	U-1231			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8686034	2025-01-24	U-1247		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8686034	2025-01-24	U-1231		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	6818787	2025-04-06		Drug substance, Drug product	2011-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8686034	2025-01-24	U-1231		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8686034	2025-01-24	U-1247		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	6818787	2025-04-06		Drug substance, Drug product	2012-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8114909	2026-04-11	U-1231			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8686034	2025-01-24	U-1247		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8686034	2025-01-24	U-1231		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	6818787	2025-04-06		Drug substance, Drug product	2011-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8686034	2025-01-24	U-1231		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8686034	2025-01-24	U-1247		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	6818787	2025-04-06		Drug substance, Drug product	2012-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8114909	2026-04-11	U-1231			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	8686034	2025-01-24	U-1247		2014-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	8686034	2025-01-24	U-1231		2014-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	6818787	2025-04-06		Drug substance, Drug product	2011-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022399-001	ODE-25	2019-06-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022399-002	ODE-25	2019-06-06	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022399-001	ODE-25	2019-06-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022399-002	ODE-25	2019-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022399-001	ODE-25	2019-06-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022399-002	ODE-25	2019-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022399-001	ODE-25	2019-06-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022399-002	ODE-25	2019-06-06	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN ENACARBIL	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
75OCL1SPBQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1101338	Internal RxNorm lookup
1101339	Internal RxNorm lookup
1482820	Internal RxNorm lookup
1482821	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53451-0101-1	Horizant	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		16
53451-0101-9	Horizant	5 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	5		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53451-0101-1	EA - Each	53451-0101	1d63b850-2f26-420c-baf1-031926135d6f	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN ENACARBIL	ACTIVE INGREDIENT	75OCL1SPBQ	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [XENOPORT INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53451-0101	HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)]	16	Current NDC, Legacy NDC, 2 package rows	20250507_4c486fc7-c8c4-4c6c-b30c-366dabaeaadd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Horizant	GABAPENTIN ENACARBIL	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022399 application number: NDA022399 ndc (product): 53451-0101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
75OCL1SPBQ	GABAPENTIN ENACARBIL	478296-72-9	GABAPENTIN ENACARBIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482820	gabapentin enacarbil 300 MG Extended Release Oral Tablet	PSN	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1101338	gabapentin enacarbil 600 MG Extended Release Oral Tablet	PSN	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1482821	Horizant 300 MG Extended Release Oral Tablet	PSN	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1101339	Horizant 600 MG Extended Release Oral Tablet	PSN	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1482821	gabapentin enacarbil 300 MG Extended Release Oral Tablet [Horizant]	SBD	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1101339	gabapentin enacarbil 600 MG Extended Release Oral Tablet [Horizant]	SBD	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1482820	gabapentin enacarbil 300 MG Extended Release Oral Tablet	SCD	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1101338	gabapentin enacarbil 600 MG Extended Release Oral Tablet	SCD	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1482821	Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral Tablet	SY	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16
1101339	Horizant 600 MG Extended Release Oral Tablet	SY	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53451-0101-1	53451010101	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)	2013-05-01	0000-00-00	No	No	Current
53451-0101-9	53451010109	5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9)	2013-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Horizant	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	2025-04-28	HUMAN PRESCRIPTION DRUG LABEL	16