gabapentin

Product NDC: 62756-202
11-digit product format: 627560202
Labeler code: 62756
Product ID: 62756-202_aff50a15-df39-495f-a145-0ba59660eed8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077525
Marketing category: ANDA
Marketing start: 2022-09-01
Substance: GABAPENTIN
Active strength: 600 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	600 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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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
62756-202-01	EA - Each	62756-202	e0c0c144-f091-4221-8eb1-4ebf55717ca9	1	2012-07-24
62756-202-03	EA - Each	62756-202	7edf1540-38ed-496c-a1c2-10543e1d9b71	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 TABLET, FILM COATED [UNIT DOSE SERVICES]	6
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]	6
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-202	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	26	Current NDC, Legacy NDC	20250529_c9a05f0c-b5f0-422c-9d67-6d0efc921a74.zip
62756-202	GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4	Current NDC, Legacy NDC	20141013_1dc96b52-7d43-4274-922f-3a070a165086.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
310433	gabapentin 600 MG Oral Tablet	PSN	d8f08084-ef02-4819-9842-727920232972	10
310433	gabapentin 600 MG Oral Tablet	SCD	d8f08084-ef02-4819-9842-727920232972	10
310433	gabapentin 600 MG Oral Tablet	PSN	7790d906-af26-4e60-bc6f-e906ec03cc24	2
310433	gabapentin 600 MG Oral Tablet	SCD	7790d906-af26-4e60-bc6f-e906ec03cc24	2
310433	gabapentin 600 MG Oral Tablet	PSN	2fe659eb-a8b4-491b-9195-fe979d7f0373	1
310434	gabapentin 800 MG Oral Tablet	PSN	2fe659eb-a8b4-491b-9195-fe979d7f0373	1
310433	gabapentin 600 MG Oral Tablet	SCD	2fe659eb-a8b4-491b-9195-fe979d7f0373	1
310434	gabapentin 800 MG Oral Tablet	SCD	2fe659eb-a8b4-491b-9195-fe979d7f0373	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-202-01	62756020201	100 TABLET, FILM COATED in 1 BOTTLE (62756-202-01)	2022-09-01	0000-00-00	No	No	Current
62756-202-02	62756020202	100 TABLET, FILM COATED in 1 BOTTLE (62756-202-02)	2006-08-24	0000-00-00	No	No	Current
62756-202-03	62756020203	500 TABLET, FILM COATED in 1 BOTTLE (62756-202-03)	2022-09-01	0000-00-00	No	No	Current
62756-202-04	62756020204	50 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (62756-202-04)	2006-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
gabapentin	Aphena Pharma Solutions - Tennessee, LLC	2022-03-21	Human Prescription Drug Label	2
gabapentin	Unit Dose Services	2017-03-06	Human Prescription Drug Label	10
Gabapentin Tablets, USP	Rebel Distributors Corp.	2009-10-23	HUMAN PRESCRIPTION DRUG LABEL	1

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#