GABAPENTIN

Product NDC: 76282-707
11-digit product format: 762820707
Labeler code: 76282
Product ID: 76282-707_96999ce4-193e-4817-939c-900ab87fc88f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA214957
Marketing category: ANDA
Marketing start: 2021-10-01
Substance: GABAPENTIN
Active strength: 800 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#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	800 mg/1

Field, Values table
Field	Values
Unii	6CW7F3G59X
Rxcui	310433, 310434

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76282-707-05	GABAPENTIN	500 in 1 BOTTLE	TABLET	500		3
76282-707-90	GABAPENTIN	90 in 1 BOTTLE	TABLET	90		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-707-05	EA - Each	76282-707	d1788a19-7ef5-40a2-8644-826bea4ba180	1	2021-12-08
76282-707-90	EA - Each	76282-707	00901da2-c5ca-44d3-a23b-588b20eeb25d	1	2021-12-08

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-707	GABAPENTIN TABLET [EXELAN PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20211125_a88edb00-2189-4c8d-9dd7-9fe1571775cc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310433	gabapentin 600 MG Oral Tablet	PSN	a88edb00-2189-4c8d-9dd7-9fe1571775cc	3
310434	gabapentin 800 MG Oral Tablet	PSN	17988b64-723c-488d-befd-3e4e4cc44bd2	3
310434	gabapentin 800 MG Oral Tablet	PSN	a88edb00-2189-4c8d-9dd7-9fe1571775cc	3
310433	gabapentin 600 MG Oral Tablet	SCD	a88edb00-2189-4c8d-9dd7-9fe1571775cc	3
310434	gabapentin 800 MG Oral Tablet	SCD	17988b64-723c-488d-befd-3e4e4cc44bd2	3
310434	gabapentin 800 MG Oral Tablet	SCD	a88edb00-2189-4c8d-9dd7-9fe1571775cc	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-707-05	76282070705	500 TABLET in 1 BOTTLE (76282-707-05)	500 tablet	2021-10-01	0000-00-00	No	No	Current
76282-707-90	76282070790	90 TABLET in 1 BOTTLE (76282-707-90)	90 tablet	2021-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	Exelan Pharmaceuticals, Inc. \| Ascent Pharmaceuticals, Inc.	2025-08-16	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	2022-05-11	HUMAN PRESCRIPTION DRUG LABEL	3