GABAPENTIN

Product NDC: 69097-815
Requested package NDC: 69097-815-07
11-digit product format: 690970815
Labeler code: 69097
Product ID: 69097-815_fdeea2da-e306-45d8-a27a-e8be090319ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA090705
Marketing category: ANDA
Marketing start: 2016-06-29
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 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
A090705-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30
A090705-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30
A090705-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090705-001	AB
A090705-002	AB
A090705-003	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	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`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	A090705-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090705-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090705-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090705-001	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 · 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
9e4eca9c-6a2c-4ede-a252-1a27094bf594	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	Strength	SPL version
69097-815-07	GABAPENTIN	100 in 1 BOTTLE	CAPSULE	100		8
69097-815-12	GABAPENTIN	500 in 1 BOTTLE	CAPSULE	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-815-07	EA - Each	69097-815	1b32d9c2-688e-4f46-8c95-8ed57cda63b8	1	2016-07-19
69097-815-12	EA - Each	69097-815	33da2998-0b63-4be4-b4db-5cfc0750dded	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-815	GABAPENTIN CAPSULE [CIPLA USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241115_9e4eca9c-6a2c-4ede-a252-1a27094bf594.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	1373587e-807a-462a-bff6-8a7113ce9f0a	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	41d1ead3-046e-4abf-ae0a-cb126a1f5848	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Cipla USA Inc.	9e4eca9c-6a2c-4ede-a252-1a27094bf594	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705 ndc (package): 69097-815-07 ndc (product): 69097-815 ndc11 (package): 69097081507
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	6e7f602a-2c5f-4651-a228-5fc5bf249205	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	1fd95278-842f-4bf9-abd5-4d9aa858d36d	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	97a1d45d-d5b3-4be7-9b3a-cb6f80f60291	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	45039bba-7a96-450c-95be-83a3aa4fcbd2	2020-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Proficient Rx LP	4bae5032-f634-4d1e-b672-8a7e2bd6a5fa	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Proficient Rx LP	92c4d589-533b-4fe4-833f-dd68cc1f7e66	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	a900bafb-8f49-4a01-ba7f-4fb228ec0253	2018-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6702ed8f-4aaf-46fa-bf39-db75154aa44c	2018-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705

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	9e4eca9c-6a2c-4ede-a252-1a27094bf594	8
310431	gabapentin 300 MG Oral Capsule	PSN	9e4eca9c-6a2c-4ede-a252-1a27094bf594	8
310432	gabapentin 400 MG Oral Capsule	PSN	9e4eca9c-6a2c-4ede-a252-1a27094bf594	8
310430	gabapentin 100 MG Oral Capsule	SCD	9e4eca9c-6a2c-4ede-a252-1a27094bf594	8
310431	gabapentin 300 MG Oral Capsule	SCD	9e4eca9c-6a2c-4ede-a252-1a27094bf594	8
310432	gabapentin 400 MG Oral Capsule	SCD	9e4eca9c-6a2c-4ede-a252-1a27094bf594	8
310432	gabapentin 400 MG Oral Capsule	PSN	92c4d589-533b-4fe4-833f-dd68cc1f7e66	3
310432	gabapentin 400 MG Oral Capsule	SCD	92c4d589-533b-4fe4-833f-dd68cc1f7e66	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-815-07	69097081507	100 CAPSULE in 1 BOTTLE (69097-815-07)	100 capsule	2016-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	Cipla USA Inc. \| InvaGen Pharmaceuticals Inc \| Ascent Pharmaceuticals Inc	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	8
GABAPENTIN 400MG	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
GABAPENTIN 400MG	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
GABAPENTIN	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN	Preferred Pharmaceuticals Inc.	2019-09-27	HUMAN PRESCRIPTION DRUG LABEL	2
GABAPENTIN	Preferred Pharmaceuticals Inc.	2019-09-26	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN	Lake Erie Medical DBA Quality Care Products LLC	2019-05-09	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN 400MG	DIRECTRX \| DIRECT RX	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	2
GABAPENTIN	NuCare Pharmaceuticals, Inc. \| NuCarePharmaceuticals, Inc.	2017-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	Preferred Pharmaceuticals Inc.	2017-02-06	HUMAN PRESCRIPTION DRUG LABEL	1