GABAPENTIN

Product NDC: 61919-640
Requested package NDC: 61919-640-72
11-digit product format: 619190640
Labeler code: 61919
Product ID: 61919-640_47e158f3-f67b-74b2-e063-6394a90ac498
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA090007
Marketing category: ANDA
Marketing start: 2015-12-30
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-640	61919-640-72	I	Inactivated by FDA		2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A090007-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21
A090007-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21
A090007-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090007-001	AB
A090007-002	AB
A090007-003	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	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`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	A090007-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090007-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: GABAPENTIN
Listing expiration: 2027-12-31

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
29a70e2d-d3fd-4e32-95dd-7ee721d87388	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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
61919-640-60	2cef2736-6134-d83d-e063-dadaa90ab31f	GABAPENTIN
61919-640-72	2cef2736-982a-d83d-e063-dadaa90ab31f	GABAPENTIN
61919-640-82	2cef2736-5ff9-d83d-e063-dadaa90ab31f	GABAPENTIN
61919-640-90	2cef2736-5ff9-d83d-e063-dadaa90ab31f	GABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-640-30	GABAPENTIN	30 in 1 BOTTLE	CAPSULE	30	8
61919-640-82	GABAPENTIN	180 in 1 BOTTLE	CAPSULE	180	3
61919-640-90	GABAPENTIN	90 in 1 BOTTLE	CAPSULE	90	3
61919-640-60	GABAPENTIN	60 in 1 BOTTLE	CAPSULE	60	1
61919-640-72	GABAPENTIN	120 in 1 BOTTLE	CAPSULE	120	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-640-30	EA - Each	61919-640	fbf6cd7f-aee9-4836-8b53-788d76eefdc8	1	2019-04-11
61919-640-60	EA - Each	61919-640	b18973da-2799-4a50-8644-67622f83615f	1	2019-09-05
61919-640-72	EA - Each	61919-640	5698190b-545d-47dc-befd-635af0d3b283	1	2019-09-05
61919-640-82	EA - Each	61919-640	cfbbdae1-2d54-4d0f-b67b-0e43b5d0f1ec	1	2021-05-05
61919-640-90	EA - Each	61919-640	8a222c35-994d-49a3-a3af-94cb90b47cd4	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	4
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAPENTIN CAPSULE [DIRECT RX]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GABAPENTIN CAPSULE [DIRECT RX]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN CAPSULE [DIRECT RX]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [DIRECT RX]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-640	GABAPENTIN CAPSULE [DIRECT RX]	7	Current NDC, Legacy NDC, 1 package rows	20240111_29a70e2d-d3fd-4e32-95dd-7ee721d87388.zip
61919-640	GABAPENTIN CAPSULE [DIRECT_RX]	3	Current NDC, Legacy NDC, 2 package rows	20230511_907853a0-9979-62e7-e053-2995a90a5aca.zip
61919-640	GABAPENTIN CAPSULE [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190810_8f9fbc86-2027-b203-e053-2a95a90af299.zip
61919-640	GABAPENTIN CAPSULE [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190810_8f9fc8a2-0d10-12f1-e053-2995a90acf3d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9814b76c-87c6-4746-b712-3269352a901b	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	915cee37-536c-4761-bdb9-b96c7ee0f956	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	DIRECT RX	29a70e2d-d3fd-4e32-95dd-7ee721d87388	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007 ndc (product): 61919-640
GABAPENTIN	GABAPENTIN	MARKSANS PHARMA LIMITED	98bb408d-c402-4da6-8f9d-5de4833dedc4	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	11645bd6-7cfe-49b2-9292-2e4b0dbb84ae	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b062f12c-a745-76d4-e053-2a95a90a3a1a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c33c4d83-cc13-4104-9e24-d4cd40b17b70	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	e2d9bd8c-3bb9-4945-8e61-7d2703d9008c	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	5769d849-4f27-4701-97ec-7e3ca07339d7	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	78088f6a-06a3-422f-b336-4a57a24adc16	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8f785189-bf66-36cc-e053-2a95a90a7cbc	2024-06-19		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	82c0ed15-9132-657d-e053-2991aa0ae90a	2024-06-14		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	2018-07-12		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
Gabapentin	GABAPENTIN	Bi-Coastal Pharma International LLC	e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b	2016-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007

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	29a70e2d-d3fd-4e32-95dd-7ee721d87388	8
310431	gabapentin 300 MG Oral Capsule	SCD	29a70e2d-d3fd-4e32-95dd-7ee721d87388	8
310431	gabapentin 300 MG Oral Capsule	PSN	907853a0-9979-62e7-e053-2995a90a5aca	3
310431	gabapentin 300 MG Oral Capsule	SCD	907853a0-9979-62e7-e053-2995a90a5aca	3
310431	gabapentin 300 MG Oral Capsule	PSN	8f9fbc86-2027-b203-e053-2a95a90af299	1
310431	gabapentin 300 MG Oral Capsule	PSN	8f9fc8a2-0d10-12f1-e053-2995a90acf3d	1
310431	gabapentin 300 MG Oral Capsule	SCD	8f9fbc86-2027-b203-e053-2a95a90af299	1
310431	gabapentin 300 MG Oral Capsule	SCD	8f9fc8a2-0d10-12f1-e053-2995a90acf3d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-640-72	61919064072	120 CAPSULE in 1 BOTTLE (61919-640-72)	120 capsule	2019-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	DIRECT RX	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	8
GABAPENTIN	Direct_Rx	2023-05-10	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN	Direct_Rx	2019-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	Direct_Rx	2019-08-08	HUMAN PRESCRIPTION DRUG LABEL	1