Gabapentin

Product NDC: 16714-661
11-digit product format: 167140661
Labeler code: 16714
Product ID: 16714-661_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA078787
Marketing category: ANDA
Marketing start: 2008-01-31
Substance: GABAPENTIN
Active strength: 100 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 1.

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
A078787-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31
A078787-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31
A078787-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078787-001	AB
A078787-002	AB
A078787-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078787-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	100 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
f7c1fd34-d615-43a2-8989-898fe11f90df	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
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
16714-661-01	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	19
16714-661-02	Gabapentin	500 in 1 BOTTLE	CAPSULE	500	19
16714-661-03	Gabapentin	1000 in 1 BOTTLE	CAPSULE	1000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-661-01	EA - Each	16714-661	0b0222bd-3df4-4f51-b1d2-4aa435c61955	1	2012-07-24
16714-661-02	EA - Each	16714-661	f21464d3-22f4-43ac-96c6-05b77e4bcb1d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	7
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-661	GABAPENTIN CAPSULE [NORTHSTAR RX LLC]	18	Current NDC, Legacy NDC, 3 package rows	20241115_f7c1fd34-d615-43a2-8989-898fe11f90df.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	6beed8eb-446c-4575-8dc8-b798623d92c7	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	912d8697-b466-48dc-88d3-d2ba90e76644	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	3dbd447f-4791-4c62-86b4-6f7928862785	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	67330eef-c976-4862-b1ae-20f30f43df76	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	efb86e22-5a84-4b33-aad0-71dd5a2c6c8f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eaf5e41e-8ed3-404e-84e0-392bebdbc0b7	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	344d67fa-092e-4e71-b96a-25c71bfa6bb1	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	bc1316b6-1fc4-4990-95a8-489881772876	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	NorthStar Rx LLC	f7c1fd34-d615-43a2-8989-898fe11f90df	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 16714-661
Gabapentin	GABAPENTIN	A-S Medication Solutions	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	1a619a14-0b63-4cba-80e7-474c9a1c90b9	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b33c18ea-554d-3cfb-e053-2a95a90a2dd1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1e28ad3d-2d34-a5d0-e063-6294a90adb9e	2024-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	ecb798a0-377d-4712-bb82-ec9d7116962f	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	3b4395f2-9440-4b67-97cc-5d16f3bdd05e	2020-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Proficient Rx LP	ded42b88-94dd-462d-bcdf-7fd34d1e49c3	2020-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Proficient Rx LP	7d77dae0-df76-4b7b-9690-713e9a60e3cd	2019-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787

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	f7c1fd34-d615-43a2-8989-898fe11f90df	19
310431	gabapentin 300 MG Oral Capsule	PSN	f7c1fd34-d615-43a2-8989-898fe11f90df	19
310432	gabapentin 400 MG Oral Capsule	PSN	f7c1fd34-d615-43a2-8989-898fe11f90df	19
310430	gabapentin 100 MG Oral Capsule	SCD	f7c1fd34-d615-43a2-8989-898fe11f90df	19
310431	gabapentin 300 MG Oral Capsule	SCD	f7c1fd34-d615-43a2-8989-898fe11f90df	19
310432	gabapentin 400 MG Oral Capsule	SCD	f7c1fd34-d615-43a2-8989-898fe11f90df	19
310430	gabapentin 100 MG Oral Capsule	PSN	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	14
310432	gabapentin 400 MG Oral Capsule	PSN	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	14
310430	gabapentin 100 MG Oral Capsule	SCD	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	14
310432	gabapentin 400 MG Oral Capsule	SCD	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	14
310430	gabapentin 100 MG Oral Capsule	PSN	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	7
310430	gabapentin 100 MG Oral Capsule	SCD	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	7
310430	gabapentin 100 MG Oral Capsule	PSN	67330eef-c976-4862-b1ae-20f30f43df76	5
310430	gabapentin 100 MG Oral Capsule	SCD	67330eef-c976-4862-b1ae-20f30f43df76	5
310430	gabapentin 100 MG Oral Capsule	PSN	7e351770-8975-4417-a599-feaa3cba7514	1
310430	gabapentin 100 MG Oral Capsule	SCD	7e351770-8975-4417-a599-feaa3cba7514	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-661-01	16714066101	100 CAPSULE in 1 BOTTLE (16714-661-01)	100 capsule	2008-01-31	0000-00-00	No	No	Current
16714-661-02	16714066102	500 CAPSULE in 1 BOTTLE (16714-661-02)	500 capsule	2008-01-31	0000-00-00	No	No	Current
16714-661-03	16714066103	1000 CAPSULE in 1 BOTTLE (16714-661-03)	1000 capsule	2008-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	A-S Medication Solutions	2026-02-09	Human Prescription Drug Label	5
Gabapentin	NorthStar Rx LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-06-25	Human Prescription Drug Label	19
Gabapentin	A-S Medication Solutions	2025-06-24	Human Prescription Drug Label	14
Gabapentin Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	PD-Rx Pharmaceuticals, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	18
Gabapentin Capsules, USP	Safecor Health, LLC	2014-08-18	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin Capsules, USP	Blenheim Pharmacal, Inc.	2010-10-13	Human Prescription Drug Label	1