GABAPENTIN

Product NDC: 61919-387
11-digit product format: 619190387
Labeler code: 61919
Product ID: 61919-387_a23fa840-b83d-d01f-e053-2995a90a4ead
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA203244
Marketing category: ANDA
Marketing start: 2018-02-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 600 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-387		I	Inactivated by FDA	2026-08-11
excluded package	package	61919-387	61919-387-30	I	Inactivated by FDA	2026-08-11
excluded package	package	61919-387	61919-387-60	I	Inactivated by FDA	2026-08-11
excluded package	package	61919-387	61919-387-72	I	Inactivated by FDA	2026-08-11
excluded package	package	61919-387	61919-387-86	I	Inactivated by FDA	2026-08-11
excluded package	package	61919-387	61919-387-90	I	Inactivated by FDA	2026-08-11

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-387-86	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-387-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-387-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-387-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-387-72	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-387-86	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-387-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-387-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-387-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-387-72	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-387-86	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-387-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-387-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-387-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-387-72	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-387-86	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-387-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-387-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-387-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-387-72	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-387-86	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-387-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-387-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-387-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-387-72	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-387-86	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-387-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-387-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-387-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-387-72	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-387-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-387-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-387-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-387-72	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-387-86	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-387-90	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-387-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-387-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-387-72	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-387-86	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-387-90	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-387-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-387-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-387-72	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-387-86	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203244-001	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2013-07-12
A203244-002	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2013-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203244-001	AB1
A203244-002	AB1

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 3 · 82 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	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1	2013-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1	2013-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB	2013-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB	2013-07-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203244-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203244-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203244-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203244-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203244-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203244-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203244-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203244-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203244-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203244-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203244-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203244-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203244-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203244-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203244-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203244-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203244-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203244-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203244-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203244-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203244-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203244-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203244-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203244-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203244-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203244-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203244-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203244-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203244-002	AB	1	`782e0a99824c…`

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
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, Related label table
NDC	Related label
61919-387-30	GABAPENTIN
61919-387-60	GABAPENTIN
61919-387-72	GABAPENTIN
61919-387-86	GABAPENTIN
61919-387-90	GABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-387-30	GABAPENTIN	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
61919-387-60	GABAPENTIN	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
61919-387-72	GABAPENTIN	120 in 1 BOTTLE	TABLET, FILM COATED	120	7
61919-387-86	GABAPENTIN	270 in 1 BOTTLE	TABLET, FILM COATED	270	7
61919-387-90	GABAPENTIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-387-30	EA - Each	61919-387	be6fdcee-d13b-4389-854b-cf821017b2f3	1	2018-04-19
61919-387-60	EA - Each	61919-387	203db489-fa9d-4332-86b9-42ac0564c2da	1	2018-04-19
61919-387-72	EA - Each	61919-387	d2df637a-c099-4097-81ef-75c27e9b1832	1	2018-04-19
61919-387-86	EA - Each	61919-387	111ec2bf-178a-408b-935a-9be2540d4979	1	2018-04-19
61919-387-90	EA - Each	61919-387	ca2bc4f5-5258-49cd-88bc-50370ee58bae	1	2018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [DIRECT RX]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [DIRECT RX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [DIRECT RX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN TABLET [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [DIRECT RX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-387	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	7	Legacy NDC, 5 package rows	20200402_01aafb0d-6cf4-406d-baad-560a6c91b33f.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	REMEDYREPACK INC.	07c8bb17-9bd4-4fab-994d-0412205b53b4	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b6db5ce9-bd4b-420d-88a7-df9d46144c81	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Strides Pharma Science Limited	bec31452-b52b-4698-ba4c-0b614780ee84	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	7d3fc163-25f0-2c61-e053-2991aa0a76e9	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	47f2a06f-4eac-4dca-aa2a-a36dd4daaea0	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b4954172-5439-48fd-8348-8a2e0d2fee62	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	c9944562-563a-423d-972c-f0313375d234	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56967a93-b3c0-4043-9241-585fc64e2624	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	0eb27e64-1488-4083-82c7-cebb8c0605de	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	ACI Healthcare USA, Inc.	d7646d5e-ca25-4ec5-9e4b-931edcb15a0e	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	39149f0e-30ed-4671-8be7-2a484f65d63b	2020-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Proficient Rx LP	8b2f38ef-0a0c-45cc-88ca-cc086bf80641	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	ba2a8352-5776-4edb-914e-ce1d18ccda32	2020-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Proficient Rx LP	c09c66fd-cb31-41dd-b00b-acc58bd809f7	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244

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
310433	gabapentin 600 MG Oral Tablet	PSN	01aafb0d-6cf4-406d-baad-560a6c91b33f	7
310433	gabapentin 600 MG Oral Tablet	SCD	01aafb0d-6cf4-406d-baad-560a6c91b33f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-387-30	61919038730	30 TABLET, FILM COATED in 1 BOTTLE (61919-387-30)	2018-02-01	0000-00-00	No	No	Current
61919-387-60	61919038760	60 TABLET, FILM COATED in 1 BOTTLE (61919-387-60)	2018-02-01	0000-00-00	No	No	Current
61919-387-72	61919038772	120 TABLET, FILM COATED in 1 BOTTLE (61919-387-72)	2018-02-01	0000-00-00	No	No	Current
61919-387-86	61919038786	270 TABLET, FILM COATED in 1 BOTTLE (61919-387-86)	2018-02-01	0000-00-00	No	No	Current
61919-387-90	61919038790	90 TABLET, FILM COATED in 1 BOTTLE (61919-387-90)	2018-02-01	0000-00-00	No	No	Current