Gabapentin

Product NDC: 50436-0428
11-digit product format: 504360428
Labeler code: 50436
Product ID: 50436-0428_84223092-9dbf-48b8-8e19-3df49a142e3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA206402
Marketing category: ANDA
Marketing start: 2015-11-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 600 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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
50436-0428-1	2023-01-30	C162847	48780-1	f386c64a-0206-0266-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
50436-0428-1	Gabapentin	90 in 1 BOTTLE	TABLET	90		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0428-1	EA - Each	50436-0428	4113e868-ba34-4dac-8166-1309385291ca	1	2021-10-08

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0428	GABAPENTIN TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20210318_2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d.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	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2
310434	gabapentin 800 MG Oral Tablet	PSN	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2
310433	gabapentin 600 MG Oral Tablet	SCD	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2
310434	gabapentin 800 MG Oral Tablet	SCD	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0428-1	50436042801	90 TABLET in 1 BOTTLE (50436-0428-1)	90 tablet	2021-03-17	0000-00-00	No	No	Current