gabapentin

Product NDC: 62756-138
11-digit product format: 627560138
Labeler code: 62756
Product ID: 62756-138_aff50a15-df39-495f-a145-0ba59660eed8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077242
Marketing category: ANDA
Marketing start: 2022-02-01
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: gabapentin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	300 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6CW7F3G59X

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-138-02	EA - Each	62756-138	7b0fc750-54a1-4405-b3e9-ac7c6677b7d8	1	2012-07-24
62756-138-04	EA - Each	62756-138	663a2b39-6001-4bbb-80a9-01c4eccccee9	1	2022-07-06
62756-138-05	EA - Each	62756-138	a516ac2c-7518-4e12-bbe0-9906f8c73be3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	10
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [DIRECT RX]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [DIRECT RX]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [DIRECT RX]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [DIRECT RX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-138	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	26	Current NDC, Legacy NDC	20250529_c9a05f0c-b5f0-422c-9d67-6d0efc921a74.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310430	gabapentin 100 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	PSN	249e184c-8996-4206-8ee3-b6faa46d3188	2
310431	gabapentin 300 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310432	gabapentin 400 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310430	gabapentin 100 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	SCD	249e184c-8996-4206-8ee3-b6faa46d3188	2
310431	gabapentin 300 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310432	gabapentin 400 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	PSN	0c214cba-66d8-46e0-9632-84f10b2ca5a4	1
310431	gabapentin 300 MG Oral Capsule	SCD	0c214cba-66d8-46e0-9632-84f10b2ca5a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-138-01	62756013801	50 CAPSULE in 1 BOX, UNIT-DOSE (62756-138-01)	50 capsule	2022-02-01	0000-00-00	No	No	Current
62756-138-02	62756013802	100 CAPSULE in 1 BOTTLE (62756-138-02)	100 capsule	2022-02-01	0000-00-00	No	No	Current
62756-138-03	62756013803	100 CAPSULE in 1 BOTTLE (62756-138-03)	100 capsule	2022-02-01	0000-00-00	No	No	Current
62756-138-04	62756013804	1000 CAPSULE in 1 BOTTLE (62756-138-04)	1000 capsule	2022-02-01	0000-00-00	No	No	Current
62756-138-05	62756013805	500 CAPSULE in 1 BOTTLE (62756-138-05)	500 capsule	2022-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Direct Rx	2015-08-21	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	Direct Rx	2015-08-13	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin Capsules, USP	TYA Pharmaceuticals	2009-10-20	HUMAN PRESCRIPTION DRUG LABEL	2

gabapentin

Additional Listing Data#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#