Gabapentin

Product NDC: 53746-103
11-digit product format: 537460103
Labeler code: 53746
Product ID: 53746-103_10e5f9be-7920-4775-801b-e1c32b996410
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA078428
Marketing category: ANDA
Marketing start: 2009-11-24
Substance: GABAPENTIN
Active strength: 400 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A078428-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25
A078428-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25
A078428-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078428-001	AB
A078428-002	AB
A078428-003	AB

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078428-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078428-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	400 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310430	Internal RxNorm lookup
310431	Internal RxNorm lookup
310432	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b11dbff5-ceee-4a63-a093-f6efebdc2f6f	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53746-103-01	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	37
53746-103-05	Gabapentin	500 in 1 BOTTLE	CAPSULE	500	37
53746-103-10	Gabapentin	1000 in 1 BOTTLE	CAPSULE	1000	37
53746-103-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-103-01	EA - Each	53746-103	e384933f-9392-4d88-ad18-46bfd2d14d19	1	2012-07-24
53746-103-05	EA - Each	53746-103	cd575883-c950-49e4-8179-7ff0c9c35247	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	26
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	26
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	8
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [UNIT DOSE SERVICES]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]	1
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-103	GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	37	Current NDC, Legacy NDC, 4 package rows	20240102_b11dbff5-ceee-4a63-a093-f6efebdc2f6f.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54dc347e-cba0-ea73-e063-6294a90ab436	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	507bf6d0-e7a2-413d-9848-cd2445a1411d	2026-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	7b404ab9-8a7e-49d4-920f-487875d14e45	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	dbedccfb-0e27-4119-93b9-241c039e045a	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals of New York LLC	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	2021-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428 ndc (product): 53746-103

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	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	37
310431	gabapentin 300 MG Oral Capsule	PSN	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	37
310432	gabapentin 400 MG Oral Capsule	PSN	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	37
310430	gabapentin 100 MG Oral Capsule	SCD	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	37
310431	gabapentin 300 MG Oral Capsule	SCD	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	37
310432	gabapentin 400 MG Oral Capsule	SCD	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	37
310430	gabapentin 100 MG Oral Capsule	PSN	7d1c0aab-5385-4d42-805c-7be2b6cdfe4b	8
310431	gabapentin 300 MG Oral Capsule	PSN	7d1c0aab-5385-4d42-805c-7be2b6cdfe4b	8
310432	gabapentin 400 MG Oral Capsule	PSN	7d1c0aab-5385-4d42-805c-7be2b6cdfe4b	8
310430	gabapentin 100 MG Oral Capsule	SCD	7d1c0aab-5385-4d42-805c-7be2b6cdfe4b	8
310431	gabapentin 300 MG Oral Capsule	SCD	7d1c0aab-5385-4d42-805c-7be2b6cdfe4b	8
310432	gabapentin 400 MG Oral Capsule	SCD	7d1c0aab-5385-4d42-805c-7be2b6cdfe4b	8
310432	gabapentin 400 MG Oral Capsule	PSN	3ec0d1db-210c-4480-8cd6-2bd8603b1085	5
310432	gabapentin 400 MG Oral Capsule	SCD	3ec0d1db-210c-4480-8cd6-2bd8603b1085	5
310430	gabapentin 100 MG Oral Capsule	PSN	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310430	gabapentin 100 MG Oral Capsule	PSN	cd2d3b9d-09cc-4342-9888-9b2e792a51ee	3
310431	gabapentin 300 MG Oral Capsule	PSN	cd2d3b9d-09cc-4342-9888-9b2e792a51ee	3
310432	gabapentin 400 MG Oral Capsule	PSN	cd2d3b9d-09cc-4342-9888-9b2e792a51ee	3
310432	gabapentin 400 MG Oral Capsule	PSN	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310430	gabapentin 100 MG Oral Capsule	SCD	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310430	gabapentin 100 MG Oral Capsule	SCD	cd2d3b9d-09cc-4342-9888-9b2e792a51ee	3
310431	gabapentin 300 MG Oral Capsule	SCD	cd2d3b9d-09cc-4342-9888-9b2e792a51ee	3
310432	gabapentin 400 MG Oral Capsule	SCD	591e0212-71ac-4f7a-b30a-8f4b745b263b	3
310432	gabapentin 400 MG Oral Capsule	SCD	cd2d3b9d-09cc-4342-9888-9b2e792a51ee	3
310431	gabapentin 300 MG Oral Capsule	PSN	06f5461f-0a34-42e1-b84a-567ffafd8e99	2
310432	gabapentin 400 MG Oral Capsule	PSN	06f5461f-0a34-42e1-b84a-567ffafd8e99	2
310431	gabapentin 300 MG Oral Capsule	SCD	06f5461f-0a34-42e1-b84a-567ffafd8e99	2
310432	gabapentin 400 MG Oral Capsule	SCD	06f5461f-0a34-42e1-b84a-567ffafd8e99	2
310430	gabapentin 100 MG Oral Capsule	PSN	d08562ff-7ebf-4669-a824-933bf66b6328	1
310431	gabapentin 300 MG Oral Capsule	PSN	d08562ff-7ebf-4669-a824-933bf66b6328	1
310432	gabapentin 400 MG Oral Capsule	PSN	5bf08c96-e0fa-4f67-ba31-c28937dd4815	1
310432	gabapentin 400 MG Oral Capsule	PSN	d08562ff-7ebf-4669-a824-933bf66b6328	1
310430	gabapentin 100 MG Oral Capsule	SCD	d08562ff-7ebf-4669-a824-933bf66b6328	1
310431	gabapentin 300 MG Oral Capsule	SCD	d08562ff-7ebf-4669-a824-933bf66b6328	1
310432	gabapentin 400 MG Oral Capsule	SCD	5bf08c96-e0fa-4f67-ba31-c28937dd4815	1
310432	gabapentin 400 MG Oral Capsule	SCD	d08562ff-7ebf-4669-a824-933bf66b6328	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-103-01	53746010301	100 CAPSULE in 1 BOTTLE (53746-103-01)	100 capsule	2009-11-24	0000-00-00	No	No	Current
53746-103-05	53746010305	500 CAPSULE in 1 BOTTLE (53746-103-05)	500 capsule	2009-11-24	0000-00-00	No	No	Current
53746-103-10	53746010310	1000 CAPSULE in 1 BOTTLE (53746-103-10)	1000 capsule	2009-11-24	0000-00-00	No	No	Current
53746-103-30	53746010330	30 CAPSULE in 1 BOTTLE (53746-103-30)	30 capsule	2009-11-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals of New York, LLC \| Amneal Pharmaceuticals, LLC	2021-02-03	HUMAN PRESCRIPTION DRUG LABEL	37
Gabapentin	McKesson Corporation dba SKY Packaging \| McKesson Corporation dba RX Pak	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin	Unit Dose Services	2017-07-01	HUMAN PRESCRIPTION DRUG LABEL	5
Gabapentin Capsules, USP	Aidarex Pharmaceuticals LLC	2012-09-25	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin Capsules, USP	Physicians Total Care, Inc.	2012-06-20	HUMAN PRESCRIPTION DRUG LABEL	8
Gabapentin Capsules	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN - STAT RX USA LLC	STAT RX USA LLC	2011-08-19	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin Capsules	Keltman Pharmaceuticals Inc.	2011-02-15	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin - Contract Pharmacy Services-PA	Contract Pharmacy Services-PA	2010-07-19	HUMAN PRESCRIPTION DRUG LABEL	2