GABAPENTIN

Product NDC: 43547-383
11-digit product format: 435470383
Labeler code: 43547
Product ID: 43547-383_287538e6-6170-46b6-b209-6ae74b376b8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Solco Healthcare U.S., LLC
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2016-09-30
Marketing end: 2022-07-10
Substance: GABAPENTIN
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43547-383		D	Discontinued by firm	2026-08-11
excluded package	package	43547-383	43547-383-03	D	Discontinued by firm	2026-08-11
excluded package	package	43547-383	43547-383-10	D	Discontinued by firm	2026-08-11
excluded package	package	43547-383	43547-383-11	D	Discontinued by firm	2026-08-11
excluded package	package	43547-383	43547-383-50	D	Discontinued by firm	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 · 60 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	43547-383-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43547-383-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43547-383-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43547-383-11	`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	43547-383-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43547-383-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43547-383-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43547-383-11	`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	43547-383-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43547-383-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43547-383-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43547-383-11	`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	43547-383-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43547-383-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43547-383-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43547-383-11	`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	43547-383-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43547-383-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43547-383-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43547-383-11	`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	43547-383-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43547-383-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43547-383-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43547-383-11	`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	43547-383-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43547-383-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43547-383-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43547-383-11	`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	43547-383-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43547-383-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43547-383-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43547-383-11	`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	43547-383-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43547-383-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43547-383-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43547-383-11	`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	43547-383-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43547-383-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43547-383-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43547-383-11	`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	43547-383-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43547-383-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43547-383-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43547-383-11	`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 package	package	43547-383-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43547-383-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43547-383-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43547-383-11	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204989-001	RELGAABI	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18
A204989-002	RELGAABI	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18
A204989-003	RELGAABI	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18
A204989-004	RELGAABI	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204989-001	AB
A204989-002	AB
A204989-003	AB
A204989-004	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 · 124 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	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 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	A204989-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204989-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204989-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204989-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204989-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204989-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204989-001	AB	1	`8072bd15b7f6…`

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, Effective, Related label table
NDC	Effective	Related label
43547-383-03	2020-03-05	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-10	2020-03-05	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-11	2020-03-05	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-50	2020-03-05	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-03	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-10	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-11	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
43547-383-50	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-383-10	EA - Each	43547-383	f52359b5-7871-40ac-937b-f190c01168cb	1	2016-11-08
43547-383-50	EA - Each	43547-383	6ee17d74-baa8-401c-821b-6f35562b96de	1	2016-11-08

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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	e877a425-2b7f-4e43-a1f9-24019cbf9685	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	dd7adad2-e2f5-4b43-90a4-522bce0be5b3	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	1b44a3ab-4d06-205f-e063-6294a90af368	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9a829dc3-b2d8-4d19-a579-0597217cec9b	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b7a29b99-ce23-950e-e053-2995a90a1934	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4c49d34d-bb47-406b-8f2d-b4834b2ee9d0	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Coupler LLC	5385e27c-f2fa-32d5-e063-6294a90a0a8c	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Direct_Rx	f8998c1c-c359-6f01-e053-6294a90aebf4	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b8b7e045-a7fe-8539-e053-2a95a90a40f8	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	100ff86c-56a8-4770-9db3-b9bc6b1bd2f7	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	e3429322-c442-4146-bb68-bcc3a8d01552	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	2625c0ef-5295-41de-9e81-88001a6cbecc	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	41dcc917-68d1-49f0-8223-44c21ca259ef	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Coupler LLC	5073abda-321f-29d1-e063-6394a90a59ac	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	PHOENIX RX LLC	4f95c01f-200e-bfd7-e063-6394a90abc38	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	48037fc4-1aab-4ae8-aede-7c55b494877a	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cb81fd89-b32b-4538-bf5c-ab02f65b3458	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2ac0622c-440a-49a0-974f-726e6ac72a0e	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989

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	55b856aa-2835-4b96-9e52-08c375179b4a	10
310431	gabapentin 300 MG Oral Capsule	PSN	55b856aa-2835-4b96-9e52-08c375179b4a	10
310430	gabapentin 100 MG Oral Capsule	SCD	55b856aa-2835-4b96-9e52-08c375179b4a	10
310431	gabapentin 300 MG Oral Capsule	SCD	55b856aa-2835-4b96-9e52-08c375179b4a	10
310430	gabapentin 100 MG Oral Capsule	PSN	6aae39b6-be82-c9b5-e053-2991aa0a7d89	4
310430	gabapentin 100 MG Oral Capsule	SCD	6aae39b6-be82-c9b5-e053-2991aa0a7d89	4
310430	gabapentin 100 MG Oral Capsule	PSN	2e319a08-901d-40a9-e054-00144ff88e88	3
310431	gabapentin 300 MG Oral Capsule	PSN	2e319a08-901d-40a9-e054-00144ff88e88	3
310434	gabapentin 800 MG Oral Tablet	PSN	2e319a08-901d-40a9-e054-00144ff88e88	3
310430	gabapentin 100 MG Oral Capsule	SCD	2e319a08-901d-40a9-e054-00144ff88e88	3
310431	gabapentin 300 MG Oral Capsule	SCD	2e319a08-901d-40a9-e054-00144ff88e88	3
310434	gabapentin 800 MG Oral Tablet	SCD	2e319a08-901d-40a9-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-383-03	43547038303	30 CAPSULE in 1 BOTTLE (43547-383-03)	30 capsule	2016-09-30	2022-07-10	No	No	Current
43547-383-10	43547038310	100 CAPSULE in 1 BOTTLE (43547-383-10)	100 capsule	2016-09-30	2022-07-10	No	No	Current
43547-383-11	43547038311	1000 CAPSULE in 1 BOTTLE (43547-383-11)	1000 capsule	2016-09-30	2022-07-10	No	No	Current
43547-383-50	43547038350	500 CAPSULE in 1 BOTTLE (43547-383-50)	500 capsule	2016-09-30	2022-07-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	Unit Dose Services	2021-12-07	HUMAN PRESCRIPTION DRUG LABEL	10
GABAPENTIN	NuCare Pharmaceuticals,Inc.	2021-02-10	HUMAN PRESCRIPTION DRUG LABEL	4
GABAPENTIN	Solco Healthcare U.S., LLC	2020-04-06	HUMAN PRESCRIPTION DRUG LABEL	6
GABAPAL	PureTek Corporation	2020-01-25	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	DIRECT RX	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	3
GABAPENTIN	St. Mary's Medical Park Pharmacy \| ScieGen Pharmaceuticals, Inc.	2018-11-13	HUMAN PRESCRIPTION DRUG LABEL	2