Gabapentin

Product NDC: 43353-081
11-digit product format: 433530081
Labeler code: 43353
Product ID: 43353-081_c53f4d79-df8d-42b8-86e3-bd6181049abc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075350
Marketing category: ANDA
Marketing start: 2014-03-17
Substance: GABAPENTIN
Active strength: 400 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], 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
A075350-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12
A075350-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12
A075350-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075350-001	AB
A075350-002	AB
A075350-003	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	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`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	A075350-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075350-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075350-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075350-001	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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	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
43353-081-60	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	1
43353-081-80	Gabapentin	180 in 1 BOTTLE	CAPSULE	180	1
43353-081-92	Gabapentin	270 in 1 BOTTLE	CAPSULE	270	1
43353-081-94	Gabapentin	360 in 1 BOTTLE	CAPSULE	360	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-081-60	EA - Each	43353-081	b7901bff-bdbb-4801-aad2-ddee722ba513	1	2016-07-19
43353-081-80	EA - Each	43353-081	b6a83efc-f146-4756-840b-a5ccf6b76bc7	1	2016-07-19
43353-081-92	EA - Each	43353-081	6a93423a-9448-496d-a47b-02aa4a7becae	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-081	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 4 package rows	20160707_86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Teva Pharmaceuticals, Inc.	c7f21eaa-68ee-420c-9c98-e997cc73a297	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	b4c7388a-19d9-4e3a-83c9-4943fb855be4	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Actavis Pharma, Inc.	5969871e-6c71-4c37-9d63-370718ccc80c	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc80b8b-da39-6fb9-e053-2a95a90a2d8e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	77754734-4125-42b1-97c8-458bcab2bcf1	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Proficient Rx LP	c7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc8	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Proficient Rx LP	f651a143-3f88-49c9-b5c4-c9af55aea76a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	37d4d465-19a5-46db-80dc-0b7334b3343a	2018-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	2016-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350 ndc (product): 43353-081

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
310431	gabapentin 300 MG Oral Capsule	PSN	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1
310432	gabapentin 400 MG Oral Capsule	PSN	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1
310431	gabapentin 300 MG Oral Capsule	SCD	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1
310432	gabapentin 400 MG Oral Capsule	SCD	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-081-60	43353008160	90 CAPSULE in 1 BOTTLE (43353-081-60)	90 capsule	2015-07-11	0000-00-00	No	No	Current
43353-081-80	43353008180	180 CAPSULE in 1 BOTTLE (43353-081-80)	180 capsule	2015-11-07	0000-00-00	No	No	Current
43353-081-92	43353008192	270 CAPSULE in 1 BOTTLE (43353-081-92)	270 capsule	2016-01-28	0000-00-00	No	No	Current
43353-081-94	43353008194	360 CAPSULE in 1 BOTTLE (43353-081-94)	360 capsule	2015-11-08	0000-00-00	No	No	Current