Gabapentin

Product NDC: 42254-109
11-digit product format: 422540109
Labeler code: 42254
Product ID: 42254-109_f8c7c414-fcd2-47dd-8226-8d0c35d3e9f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA077662
Marketing category: ANDA
Marketing start: 2011-02-09
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: 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
42254-109-30	2019-09-24	C162847	48780-1	9350213a-3c29-c013-e053-90daa90a1393	Gabapentin Tablets USP
42254-109-60	2019-09-24	C162847	48780-1	9350213a-3c29-c013-e053-90daa90a1393	Gabapentin Tablets USP
42254-109-90	2019-09-24	C162847	48780-1	9350213a-3c29-c013-e053-90daa90a1393	Gabapentin Tablets USP

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42254-109-30	Gabapentin	30 in 1 BOTTLE, PLASTIC	TABLET	30	4
42254-109-60	Gabapentin	60 in 1 BOTTLE, PLASTIC	TABLET	60	4
42254-109-90	Gabapentin	90 in 1 BOTTLE, PLASTIC	TABLET	90	4

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-109-30	EA - Each	42254-109	dee6a99d-41dd-44a0-8bbb-4268aab664ec	1	2012-07-24
42254-109-60	EA - Each	42254-109	f5754894-73b5-43a1-9bc6-a06143a45dbc	1	2013-03-03
42254-109-90	EA - Each	42254-109	4ca721b0-d519-4bc0-95db-4b2c959d3995	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-109	GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]	4	Legacy NDC, 3 package rows	20130221_5dbdcf46-c0d9-4249-81fa-75bef5a69d84.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	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310434	gabapentin 800 MG Oral Tablet	PSN	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310433	gabapentin 600 MG Oral Tablet	SCD	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4
310434	gabapentin 800 MG Oral Tablet	SCD	5dbdcf46-c0d9-4249-81fa-75bef5a69d84	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-109-30	42254010930	30 in 1 BOTTLE, PLASTIC	Historical
42254-109-60	42254010960	60 in 1 BOTTLE, PLASTIC	Historical
42254-109-90	42254010990	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin Tablets USP	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	4