Gabapentin

Product NDC: 66336-439
11-digit product format: 663360439
Labeler code: 66336
Product ID: 66336-439_7d9f35d2-ad0e-415c-b145-10382b7b5a7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA078150
Marketing category: ANDA
Marketing start: 2007-07-09
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 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
66336-439-55	2019-11-27	C162847	48780-1	9855d018-de47-cd31-e053-dbdaa90ab51a	GABAPENTIN CAPSULES, USP Rx Only Rev. 09/2011
66336-439-62	2019-11-27	C162847	48780-1	9855d018-de47-cd31-e053-dbdaa90ab51a	GABAPENTIN CAPSULES, USP Rx Only Rev. 09/2011

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66336-439-55	Gabapentin	150 in 1 BOTTLE	CAPSULE	150		2
66336-439-62	Gabapentin	180 in 1 BOTTLE	CAPSULE	180		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-439	GABAPENTIN CAPSULE [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 2 package rows	20130814_f4cb6e7e-7041-4753-8192-35a73ef9782f.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	f4cb6e7e-7041-4753-8192-35a73ef9782f	2
310431	gabapentin 300 MG Oral Capsule	PSN	f4cb6e7e-7041-4753-8192-35a73ef9782f	2
310430	gabapentin 100 MG Oral Capsule	SCD	f4cb6e7e-7041-4753-8192-35a73ef9782f	2
310431	gabapentin 300 MG Oral Capsule	SCD	f4cb6e7e-7041-4753-8192-35a73ef9782f	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-439-55	66336043955	150 in 1 BOTTLE	Historical
66336-439-62	66336043962	180 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN CAPSULES, USP Rx Only Rev. 09/2011	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-08-13	HUMAN PRESCRIPTION DRUG LABEL	2