Gabapentin

Product NDC: 71205-533
11-digit product format: 712050533
Labeler code: 71205
Product ID: 71205-533_6277f808-3745-48d5-944c-14af994b3690
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2016-02-04
Substance: GABAPENTIN
Active strength: 600 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205101-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2016-02-04
A205101-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2016-02-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205101-001	AB1
A205101-002	AB1

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205101-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205101-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205101-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205101-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205101-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	AB	1	`74a2ff9319b5…`

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	600 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310433	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
2fb2233f-9152-4630-ab39-51a0cda7e5ca	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-533-30	Gabapentin	30 in 1 BOTTLE	TABLET	30	3
71205-533-60	Gabapentin	60 in 1 BOTTLE	TABLET	60	3
71205-533-90	Gabapentin	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-533-30	EA - Each	71205-533	74425d20-dd45-4fc0-88fe-27d2f71f24d4	1	2021-10-08
71205-533-90	EA - Each	71205-533	2ffba78c-6d49-4847-b35e-b6c4cd01eb4b	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-533	GABAPENTIN TABLET [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20220426_2fb2233f-9152-4630-ab39-51a0cda7e5ca.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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7a2aa696-7dac-4d03-916a-374b61a255b5	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	79cd9dea-e7d0-44db-afba-964cb99f32b6	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f9bf87e4-5499-4dd7-a0c1-16025a718d14	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	9c96b488-19bd-431e-af9a-b313ffd9eaae	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	af62bb7e-162e-4e2a-8eb0-d50f66678707	2023-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	35004f84-90ae-45f0-a2ba-653dec507229	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9d544944-ea95-42e1-8c65-9e442437f0ee	2022-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	c18d9d06-f796-4eb7-8fd5-1de4ebb95439	2022-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	b67b7865-df64-429a-9550-5333b9c713ea	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	2fb2233f-9152-4630-ab39-51a0cda7e5ca	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101 ndc (product): 71205-533
Gabapentin	GABAPENTIN	Proficient Rx LP	2b76955c-52a4-4026-b286-3da1112fe989	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101

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	2fb2233f-9152-4630-ab39-51a0cda7e5ca	3
310433	gabapentin 600 MG Oral Tablet	SCD	2fb2233f-9152-4630-ab39-51a0cda7e5ca	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-533-30	71205053330	30 TABLET in 1 BOTTLE (71205-533-30)	30 tablet	2021-02-09	0000-00-00	No	No	Current
71205-533-60	71205053360	60 TABLET in 1 BOTTLE (71205-533-60)	60 tablet	2021-02-09	0000-00-00	No	No	Current
71205-533-90	71205053390	90 TABLET in 1 BOTTLE (71205-533-90)	90 tablet	2021-02-09	0000-00-00	No	No	Current