Gabapentin

Product NDC: 42254-103
11-digit product format: 422540103
Labeler code: 42254
Product ID: 42254-103_3345e995-7c5a-4e1c-949a-396ca7332023
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA078428
Marketing category: ANDA
Marketing start: 2009-11-24
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
42254-103-30	2019-09-24	C162847	48780-1	9350213a-3dbb-c013-e053-90daa90a1393	Gabapentin Capsules
42254-103-60	2019-09-24	C162847	48780-1	9350213a-3dbb-c013-e053-90daa90a1393	Gabapentin Capsules
42254-103-90	2019-09-24	C162847	48780-1	9350213a-3dbb-c013-e053-90daa90a1393	Gabapentin Capsules

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42254-103-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	3
42254-103-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	3
42254-103-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-103-30	EA - Each	42254-103	467e179f-cd65-4d8f-b4fd-04479e3a06de	1	2012-07-24
42254-103-60	EA - Each	42254-103	cb919a6e-8fd5-4e5f-912b-b67b6acd4910	1	2012-07-24
42254-103-90	EA - Each	42254-103	793ed173-7479-456b-bbaf-9e4ba21fad02	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]	3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-103	GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]	3	Legacy NDC, 3 package rows	20121208_591e0212-71ac-4f7a-b30a-8f4b745b263b.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
310430	gabapentin 100 MG Oral Capsule	PSN	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310432	gabapentin 400 MG Oral Capsule	PSN	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310430	gabapentin 100 MG Oral Capsule	SCD	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310432	gabapentin 400 MG Oral Capsule	SCD	591e0212-71ac-4f7a-b30a-8f4b745b263b	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-103-30	42254010330	30 in 1 BOTTLE	Historical
42254-103-60	42254010360	60 in 1 BOTTLE	Historical
42254-103-90	42254010390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin Capsules	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	3