Gabapentin

Product NDC: 52959-757
11-digit product format: 529590757
Labeler code: 52959
Product ID: 52959-757_3b0ebf5d-a084-4322-a1f4-602566b5a9c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA090705
Marketing category: ANDA
Marketing start: 2010-05-17
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
52959-757-01	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-02	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-03	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-20	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-21	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-27	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-30	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-60	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-80	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP
52959-757-90	2019-11-13	C162847	48780-1	97449f38-ccaa-f6ea-e053-dbdaa90aa703	Gabapentin Capsules, USP

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-757-01	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	1
52959-757-02	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	1
52959-757-03	Gabapentin	3 in 1 BOTTLE	CAPSULE	3	1
52959-757-20	Gabapentin	20 in 1 BOTTLE	CAPSULE	20	1
52959-757-21	Gabapentin	21 in 1 BOTTLE	CAPSULE	21	1
52959-757-27	Gabapentin	270 in 1 BOTTLE	CAPSULE	270	1
52959-757-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	1
52959-757-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	1
52959-757-80	Gabapentin	80 in 1 BOTTLE	CAPSULE	80	1
52959-757-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-757-01	EA - Each	52959-757	9d5652cc-61bd-4da6-872d-5c2332d1135b	1	2012-07-24
52959-757-02	EA - Each	52959-757	198b1719-3351-4e9c-a8fd-3313c2a44f32	1	2012-07-24
52959-757-03	EA - Each	52959-757	ff88f2f5-50e2-4e08-9951-d039a5a82cc2	1	2012-07-24
52959-757-20	EA - Each	52959-757	8923bf12-c558-4598-9b7d-feb3784d54aa	1	2012-07-24
52959-757-21	EA - Each	52959-757	7646cbbc-665f-4b9b-8f1c-afc2e878f2c3	1	2012-07-24
52959-757-27	EA - Each	52959-757	ff04b226-b3fe-4a14-8caf-8d064c85a498	1	2012-07-24
52959-757-30	EA - Each	52959-757	1759e012-7737-4013-b46b-56648c2b9c03	1	2012-07-24
52959-757-60	EA - Each	52959-757	f33cfc38-208f-45fa-b9dc-51a2ec694daa	1	2012-07-24
52959-757-80	EA - Each	52959-757	0987675a-1004-4767-b122-fa0d2f8872f7	1	2012-07-24
52959-757-90	EA - Each	52959-757	72b76a2d-14db-42df-8441-88ede7273d41	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-757	GABAPENTIN CAPSULE [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 10 package rows	20120215_99adb2c7-4725-4768-a2d9-856a87f33192.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	99adb2c7-4725-4768-a2d9-856a87f33192	1
310430	gabapentin 100 MG Oral Capsule	SCD	99adb2c7-4725-4768-a2d9-856a87f33192	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-757-01	52959075701	100 in 1 BOTTLE	Historical
52959-757-02	52959075702	120 in 1 BOTTLE	Historical
52959-757-03	52959075703	3 in 1 BOTTLE	Historical
52959-757-20	52959075720	20 in 1 BOTTLE	Historical
52959-757-21	52959075721	21 in 1 BOTTLE	Historical
52959-757-27	52959075727	270 in 1 BOTTLE	Historical
52959-757-30	52959075730	30 in 1 BOTTLE	Historical
52959-757-60	52959075760	60 in 1 BOTTLE	Historical
52959-757-80	52959075780	80 in 1 BOTTLE	Historical
52959-757-90	52959075790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin Capsules, USP	H.J. Harkins Company, Inc. \| Camber Pharmaceuticals Inc. \| Invagen Pharmaceuticals	2012-02-03	HUMAN PRESCRIPTION DRUG LABEL	1