Gabapentin

Product NDC: 45865-995
11-digit product format: 458650995
Labeler code: 45865
Product ID: 45865-995_9af351e3-1a99-7523-e053-2a95a90a9ca9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA203244
Marketing category: ANDA
Marketing start: 2014-01-11
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-995-90	2023-01-30	C162847	48780-1	f386c649-d6fd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-995-90	Gabapentin	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-995	GABAPENTIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20191231_9af351e3-1a98-7523-e053-2a95a90a9ca9.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
310434	gabapentin 800 MG Oral Tablet	PSN	9af351e3-1a98-7523-e053-2a95a90a9ca9	1
310434	gabapentin 800 MG Oral Tablet	SCD	9af351e3-1a98-7523-e053-2a95a90a9ca9	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-995-90	45865099590	90 TABLET, FILM COATED in 1 BOTTLE (45865-995-90)	2019-12-11	0000-00-00	No	No	Current