gabapentin

Product NDC: 62756-138
11-digit product format: 627560138
Labeler code: 62756
Product ID: 62756-138_ca2658ac-c659-4217-8625-a1043d211cd5
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	62756-138	62756-138-02	D	Discontinued by firm	2026-10-05
excluded package	package	62756-138	62756-138-04	D	Discontinued by firm	2026-10-05
excluded package	package	62756-138	62756-138-05	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077242-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24
A077242-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24
A077242-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A077242-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077242-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077242-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077242-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077242-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077242-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077242-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077242-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077242-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077242-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077242-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077242-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077242-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077242-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077242-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077242-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077242-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077242-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077242-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077242-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077242-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077242-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077242-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077242-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077242-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077242-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077242-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077242-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077242-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077242-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077242-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077242-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077242-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077242-001	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: gabapentin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6CW7F3G59X	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c9a05f0c-b5f0-422c-9d67-6d0efc921a74	Available on FDA.report

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 [DIRECT RX]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	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 [TYA PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	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 [DIRECT RX]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	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 (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	1
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	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 (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	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 (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN (GABAPENTIN) CAPSULE [PHARMACEUTICA NORTH AMERICA, INC.]	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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	Sun Pharmaceutical Industries, Inc.	c9a05f0c-b5f0-422c-9d67-6d0efc921a74	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077242 application number: ANDA077242 ndc (product): 62756-138

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	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-05-23	Human Prescription Drug Label	26
gabapentin	A-S Medication Solutions	2017-12-26	Human Prescription Drug Label	4
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	Pharmaceutica North America, Inc.	2014-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin Capsules, USP	TYA Pharmaceuticals	2009-10-20	HUMAN PRESCRIPTION DRUG LABEL	2