Gabapentin

Product NDC: 52959-789
11-digit product format: 529590789
Labeler code: 52959
Product ID: 52959-789_1199caa8-cf89-4168-94d1-56bd48557325
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA077662
Marketing category: ANDA
Marketing start: 2006-04-01
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: 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
52959-789-02	2019-11-13	C162847	48780-1	97449f38-cd37-f6ea-e053-dbdaa90aa703	Gabapentin Tablets USP
52959-789-30	2019-11-13	C162847	48780-1	97449f38-cd37-f6ea-e053-dbdaa90aa703	Gabapentin Tablets USP
52959-789-60	2019-11-13	C162847	48780-1	97449f38-cd37-f6ea-e053-dbdaa90aa703	Gabapentin Tablets USP
52959-789-63	2019-11-13	C162847	48780-1	97449f38-cd37-f6ea-e053-dbdaa90aa703	Gabapentin Tablets USP
52959-789-90	2019-11-13	C162847	48780-1	97449f38-cd37-f6ea-e053-dbdaa90aa703	Gabapentin Tablets USP

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-789-02	Gabapentin	120 in 1 BOTTLE	TABLET	120	3
52959-789-30	Gabapentin	30 in 1 BOTTLE	TABLET	30	3
52959-789-60	Gabapentin	60 in 1 BOTTLE	TABLET	60	3
52959-789-63	Gabapentin	63 in 1 BOTTLE	TABLET	63	3
52959-789-90	Gabapentin	90 in 1 BOTTLE	TABLET	90	3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-789-30	EA - Each	52959-789	c83703f8-670a-4016-adac-2ec4603a3a09	1	2012-07-24
52959-789-60	EA - Each	52959-789	b6e2ff35-1b4c-4e90-8ad1-51340ece8791	1	2012-07-24
52959-789-63	EA - Each	52959-789	e47fb790-d7fe-426d-8f3c-74c0f40516e3	1	2012-07-24
52959-789-90	EA - Each	52959-789	790a0e97-612e-43cf-9ae0-6e90647d7dae	1	2012-07-24

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-789	GABAPENTIN TABLET [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 5 package rows	20120419_4e37278a-7d7f-4b6d-aaa6-1a808234af9e.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	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310434	gabapentin 800 MG Oral Tablet	PSN	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310433	gabapentin 600 MG Oral Tablet	SCD	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3
310434	gabapentin 800 MG Oral Tablet	SCD	4e37278a-7d7f-4b6d-aaa6-1a808234af9e	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-789-02	52959078902	120 in 1 BOTTLE	Historical
52959-789-30	52959078930	30 in 1 BOTTLE	Historical
52959-789-60	52959078960	60 in 1 BOTTLE	Historical
52959-789-63	52959078963	63 in 1 BOTTLE	Historical
52959-789-90	52959078990	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin Tablets USP	H.J. Harkins Company, Inc. \| Glenmark Generics Inc., USA \| Glenmark Generics Limited	2012-04-18	HUMAN PRESCRIPTION DRUG LABEL	3