Gralise

Product NDC: 52427-815
11-digit product format: 524270815
Labeler code: 52427
Product ID: 52427-815_f0b82966-eb8f-ffed-1796-320fcd40b3c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: KIT
Labeler: Almatica Pharma LLC
Application: NDA022544
Marketing category: NDA
Marketing start: 2020-10-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52427-815		D	Discontinued by firm		2026-08-10
excluded package	package	52427-815	52427-815-99	D	Discontinued by firm		2026-08-10

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52427-815-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52427-815-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52427-815-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52427-815-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52427-815-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52427-815-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52427-815-99	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52427-815-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52427-815-99	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52427-815-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52427-815-99	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022544-001	GRALISE	GABAPENTIN	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28
N022544-002	GRALISE	GABAPENTIN	600MG	TABLET / ORAL	AB2	RLD	2011-01-28
N022544-003	GRALISE	GABAPENTIN	450MG	TABLET / ORAL	AB	RLD	2023-04-18
N022544-004	GRALISE	GABAPENTIN	750MG	TABLET / ORAL	AB	RLD	2023-04-18
N022544-005	GRALISE	GABAPENTIN	900MG	TABLET / ORAL	AB	RLD, RS	2023-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N022544-001	AB2
N022544-002	AB2
N022544-003	AB
N022544-004	AB
N022544-005	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 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-003	GRALISE	450MG	TABLET / ORAL	AB	RLD	2023-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-004	GRALISE	750MG	TABLET / ORAL	AB	RLD	2023-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-005	GRALISE	900MG	TABLET / ORAL	AB	RLD, RS	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-003	GRALISE	450MG	TABLET / ORAL	AB	RLD	2023-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-004	GRALISE	750MG	TABLET / ORAL	AB	RLD	2023-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-005	GRALISE	900MG	TABLET / ORAL	AB	RLD, RS	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022544-003	GRALISE	450MG	TABLET / ORAL		RLD	2023-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022544-004	GRALISE	750MG	TABLET / ORAL		RLD	2023-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022544-005	GRALISE	900MG	TABLET / ORAL		RLD, RS	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-003	GRALISE	450MG	TABLET / ORAL		RLD	2023-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-004	GRALISE	750MG	TABLET / ORAL		RLD	2023-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-005	GRALISE	900MG	TABLET / ORAL		RLD, RS	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-003	GRALISE	450MG	TABLET / ORAL		RLD	2023-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-004	GRALISE	750MG	TABLET / ORAL		RLD	2023-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-005	GRALISE	900MG	TABLET / ORAL		RLD, RS	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-003	GRALISE	450MG	TABLET / ORAL		RLD	2023-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-004	GRALISE	750MG	TABLET / ORAL		RLD	2023-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-005	GRALISE	900MG	TABLET / ORAL		RLD, RS	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-003	GRALISE	450MG	TABLET / ORAL		RLD	2023-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-004	GRALISE	750MG	TABLET / ORAL		RLD	2023-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-005	GRALISE	900MG	TABLET / ORAL		RLD, RS	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-001	GRALISE	300MG	TABLET / ORAL	AB2	RLD, RS	2011-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-002	GRALISE	600MG	TABLET / ORAL	AB2	RLD	2011-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-003	GRALISE	450MG	TABLET / ORAL		RLD	2023-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-004	GRALISE	750MG	TABLET / ORAL		RLD	2023-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-005	GRALISE	900MG	TABLET / ORAL		RLD, RS	2023-04-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 91 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	N022544-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022544-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022544-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022544-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022544-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022544-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022544-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022544-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022544-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022544-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022544-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022544-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022544-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022544-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022544-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022544-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022544-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022544-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022544-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022544-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022544-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022544-002	BX	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 244 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022544-002	7438927	2024-02-26	U-1114			`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022544-002	7438927	2024-02-26	U-1114			`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022544-002	7438927	2024-02-26	U-1114			`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022544-002	7438927	2024-02-26	U-1114			`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022544-002	7438927	2024-02-26	U-1114			`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022544-002	7438927	2024-02-26	U-1114			`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022544-002	7438927	2024-02-26	U-1114			`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022544-002	7438927	2024-02-26	U-1114			`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022544-002	7438927	2024-02-26	U-1114			`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-001	7731989	2022-10-25		Drug product	2011-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-001	8192756	2022-10-25	U-1114	Drug product	2012-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-001	8252332	2022-10-25	U-1114	Drug product	2012-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-001	8333992	2022-10-25	U-1114	Drug product	2013-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-002	7731989	2022-10-25		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-002	8192756	2022-10-25	U-1114	Drug product	2012-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-002	8252332	2022-10-25	U-1114	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-002	8333992	2022-10-25	U-1114	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022544-002	7438927	2024-02-26	U-1114			`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022544-001	7731989	2022-10-25		Drug product	2011-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-001	8192756	2022-10-25	U-1114	Drug product	2012-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-001	8252332	2022-10-25	U-1114	Drug product	2012-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-001	8333992	2022-10-25	U-1114	Drug product	2013-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-001	7438927	2024-02-26	U-1114		2011-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-002	7731989	2022-10-25		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-002	8192756	2022-10-25	U-1114	Drug product	2012-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-002	8252332	2022-10-25	U-1114	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-002	8333992	2022-10-25	U-1114	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022544-002	7438927	2024-02-26	U-1114			`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022544-001	7731989	2022-10-25		Drug product	2011-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022544-001	8192756	2022-10-25	U-1114	Drug product	2012-06-08	`4b0b4de00fa7…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52427-815-99	Gralise	1 in 1 BLISTER PACK	KIT	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52427-815-99	EA - Each	52427-815	8a7bcead-5829-46e3-b8c9-efd155760aef	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52427-815	GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE (GABAPENTIN) KIT [ALMATICA PHARMA LLC]	5	Legacy NDC, 1 package rows	20240704_466273b1-c9fc-3930-c94b-aa11394d5140.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gralise	GABAPENTIN	Almatica Pharma LLC	466273b1-c9fc-3930-c94b-aa11394d5140	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022544 application number: NDA022544 ndc (product): 52427-815

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
2398512	{9 (Once-Daily gabapentin 300 MG Oral Tablet [Gralise]) / 24 (Once-Daily gabapentin 600 MG Oral Tablet [Gralise]) } Pack [Gralise Sample Pack]	BPCK	466273b1-c9fc-3930-c94b-aa11394d5140	6
2398511	{9 (Once-Daily gabapentin 300 MG Oral Tablet) / 24 (Once-Daily gabapentin 600 MG Oral Tablet) } Pack	GPCK	466273b1-c9fc-3930-c94b-aa11394d5140	6
1806380	gabapentin 300 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634747	gabapentin 450 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
1806382	gabapentin 600 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634751	gabapentin 750 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634743	gabapentin 900 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2398511	gabapentin sample pack 300 MG (9), 600 MG (24) Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115012	Gralise 300 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634749	Gralise 450 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115013	Gralise 600 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634753	Gralise 750 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634745	Gralise 900 MG Once-Daily Oral Tablet	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
2398512	Gralise Sample Pack	PSN	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115012	Once-Daily gabapentin 300 MG Oral Tablet [Gralise]	SBD	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634749	Once-Daily gabapentin 450 MG Oral Tablet [Gralise]	SBD	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115013	Once-Daily gabapentin 600 MG Oral Tablet [Gralise]	SBD	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634753	Once-Daily gabapentin 750 MG Oral Tablet [Gralise]	SBD	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634745	Once-Daily gabapentin 900 MG Oral Tablet [Gralise]	SBD	466273b1-c9fc-3930-c94b-aa11394d5140	6
1806380	Once-Daily gabapentin 300 MG Oral Tablet	SCD	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634747	Once-Daily gabapentin 450 MG Oral Tablet	SCD	466273b1-c9fc-3930-c94b-aa11394d5140	6
1806382	Once-Daily gabapentin 600 MG Oral Tablet	SCD	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634751	Once-Daily gabapentin 750 MG Oral Tablet	SCD	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634743	Once-Daily gabapentin 900 MG Oral Tablet	SCD	466273b1-c9fc-3930-c94b-aa11394d5140	6
1806380	gabapentin 300 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634747	gabapentin 450 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
1806382	gabapentin 600 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634751	gabapentin 750 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634743	gabapentin 900 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2398511	gabapentin sample pack {9 (gabapentin 300 MG Once-Daily Oral Tablet) / 24 (gabapentin 600 MG Once-Daily Oral Tablet) }	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2398512	Gralise 15-Day Sample Pack	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115012	Gralise 300 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634749	Gralise 450 MG Oral Tablet, Once Daily	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115013	Gralise 600 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634753	Gralise 750 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634745	Gralise 900 MG Once-Daily Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115012	Once-Daily Gralise 300 MG Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634749	Once-Daily Gralise 450 MG Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
1115013	Once-Daily Gralise 600 MG Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634753	Once-Daily Gralise 750 MG Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6
2634745	Once-Daily Gralise 900 MG Oral Tablet	SY	466273b1-c9fc-3930-c94b-aa11394d5140	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52427-815-99	52427081599	1 KIT in 1 BLISTER PACK (52427-815-99)	1 kit	2020-10-01	0000-00-00	Yes	No	Current