Gabapentin

Product NDC: 68071-3527
Requested package NDC: 68071-3527-3
11-digit product format: 680713527
Labeler code: 68071
Product ID: 68071-3527_2d3f8d53-7483-27fd-e063-6294a90a2171
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA075477
Marketing category: ANDA
Marketing start: 2021-11-01
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3527	68071-3527-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3527	68071-3527-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3527	68071-3527-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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	TE codes	Approval date
A075477-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23
A075477-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23
A075477-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075477-001	AB
A075477-002	AB
A075477-003	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 · 129 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	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A075477-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075477-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075477-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075477-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075477-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075477-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075477-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075477-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075477-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-001	AB	1	`301d65b070ca…`

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: 2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310431	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
0919fed8-e968-b5ac-e063-6294a90afbff	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3527-3	2025-02-03	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
68071-3527-6	2025-02-03	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
68071-3527-9	2025-02-03	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
68071-3527-3	2025-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
68071-3527-6	2025-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
68071-3527-9	2025-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3527-3	Gabapentin	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	4
68071-3527-6	Gabapentin	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	4
68071-3527-9	Gabapentin	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3527	GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, 3 package rows	20250205_0919fed8-e968-b5ac-e063-6294a90afbff.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Proficient Rx LP	9d401e54-d4f5-43ba-b898-dd08fc3c7bfa	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	74474aa4-4859-42d2-92d8-f23f18b34e04	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Proficient Rx LP	3c8dca11-78ab-45c1-8bb2-89a41ea5dfa9	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	3ad96553-73a4-4a9b-8a89-10a29b794ed3	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	0919fed8-e968-b5ac-e063-6294a90afbff	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477 ndc (package): 68071-3527-3 ndc (product): 68071-3527 ndc11 (package): 68071352703
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ec1c621b-db2a-1567-e053-2995a90a8695	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ebf57adf-b066-2959-e053-2a95a90a961c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	f781d400-7304-5d3e-e053-6294a90ac572	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477

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	0919fed8-e968-b5ac-e063-6294a90afbff	4
310431	gabapentin 300 MG Oral Capsule	SCD	0919fed8-e968-b5ac-e063-6294a90afbff	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3527-3	68071352703	30 CAPSULE in 1 BOTTLE, PLASTIC (68071-3527-3)	30 capsule	2023-11-01	No	No	Current