Gabapentin

Product NDC: 50436-7284
11-digit product format: 504367284
Labeler code: 50436
Product ID: 50436-7284_cc44dcb8-0938-4c45-b6e6-b603d1c6d0e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA078428
Marketing category: ANDA
Marketing start: 2009-11-24
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 400 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
50436-7284-1	2021-01-29	C162847	48780-1	ba0f9c33-1874-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
50436-7284-2	2021-01-29	C162847	48780-1	ba0f9c33-1874-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
50436-7284-3	2021-01-29	C162847	48780-1	ba0f9c33-1874-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-7284-1	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	5
50436-7284-2	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	5
50436-7284-3	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-7284	GABAPENTIN CAPSULE [UNIT DOSE SERVICES]	5	Legacy NDC, 3 package rows	20170702_3ec0d1db-210c-4480-8cd6-2bd8603b1085.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
310432	gabapentin 400 MG Oral Capsule	PSN	3ec0d1db-210c-4480-8cd6-2bd8603b1085	5
310432	gabapentin 400 MG Oral Capsule	SCD	3ec0d1db-210c-4480-8cd6-2bd8603b1085	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-7284-1	50436728401	30 in 1 BOTTLE	Historical
50436-7284-2	50436728402	60 in 1 BOTTLE	Historical
50436-7284-3	50436728403	90 in 1 BOTTLE	Historical