GABAPENTIN

Product NDC: 61919-102
11-digit product format: 619190102
Labeler code: 61919
Product ID: 61919-102_7d9af18b-1edc-4f6b-a4aa-5cca7652b600
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct Rx
Application: ANDA077242
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-102		I	Inactivated by FDA	2026-10-05
excluded product	product	61919-102		I	Inactivated by FDA	2026-10-05
excluded package	package	61919-102	61919-102-71	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-102	61919-102-72	I	Inactivated by FDA	2026-10-05

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 2 · 88 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-102-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-102-71	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-102-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-102-71	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-102-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-102-71	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-102-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-102-71	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-102-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-102-71	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-102-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-102-71	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-102-72	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-102-71	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-102-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-102-71	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-102-72	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-102-71	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-102-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-102-71	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-102-72	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-102-71	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-102-72	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-102-71	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-102-72	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-102-71	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-102-72	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-102-71	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-102-72	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-102-71	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A077242-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24
A077242-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24
A077242-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A077242-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077242-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077242-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077242-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077242-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077242-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077242-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077242-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077242-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077242-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077242-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077242-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077242-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077242-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077242-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077242-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077242-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077242-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077242-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077242-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077242-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077242-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077242-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077242-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077242-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077242-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077242-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077242-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077242-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077242-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077242-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077242-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077242-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077242-001	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-102-71	2020-01-31	C162847	48780-1	9d75b9d0-a68a-f424-e053-dadaa90a57ce	Gabapentin
61919-102-72	2020-01-31	C162847	48780-1	9d75b9d0-7987-f424-e053-dadaa90a57ce	GABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-102-30	GABAPENTIN	30 in 1 BOTTLE	CAPSULE	30	2
61919-102-60	GABAPENTIN	60 in 1 BOTTLE	CAPSULE	60	2
61919-102-72	GABAPENTIN	120 in 1 BOTTLE	CAPSULE	120	2
61919-102-90	GABAPENTIN	90 in 1 BOTTLE	CAPSULE	90	2
61919-102-71	Gabapentin	100 in 1 BOTTLE	Capsule	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-102-30	EA - Each	61919-102	5fe071c5-fbed-45c3-ba66-c2a71c5693ee	1	2014-05-02
61919-102-60	EA - Each	61919-102	003af925-1410-4989-a13c-ffe9058880c9	1	2014-05-02
61919-102-72	EA - Each	61919-102	83133469-9868-4a43-80d0-87c0d8bd4998	1	2014-05-02
61919-102-90	EA - Each	61919-102	cbac1060-243c-4ad5-8d21-c5037c89eae7	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [DIRECT RX]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [DIRECT RX]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	2
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [DIRECT RX]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [DIRECT RX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-102	GABAPENTIN CAPSULE [DIRECT RX]	2	Legacy NDC, 4 package rows	20150814_52e49778-03f1-43cb-b75d-6c1adbb96ec6.zip
61919-102	GABAPENTIN CAPSULE [DIRECT RX]	1	Legacy NDC, 1 package rows	20150822_0c214cba-66d8-46e0-9632-84f10b2ca5a4.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
gabapentin	GABAPENTIN	Sun Pharmaceutical Industries, Inc.	c9a05f0c-b5f0-422c-9d67-6d0efc921a74	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077242 application number: ANDA077242

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	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310432	gabapentin 400 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310430	gabapentin 100 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310432	gabapentin 400 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	PSN	0c214cba-66d8-46e0-9632-84f10b2ca5a4	1
310431	gabapentin 300 MG Oral Capsule	SCD	0c214cba-66d8-46e0-9632-84f10b2ca5a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-102-30	61919010230	30 in 1 BOTTLE	Historical
61919-102-60	61919010260	60 in 1 BOTTLE	Historical
61919-102-71	61919010271	100 in 1 BOTTLE	Historical
61919-102-72	61919010272	120 in 1 BOTTLE	Historical
61919-102-90	61919010290	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Direct Rx	2015-08-21	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	Direct Rx	2015-08-13	HUMAN PRESCRIPTION DRUG LABEL	2