GABAPENTIN

Product NDC: 43063-758
11-digit product format: 430630758
Labeler code: 43063
Product ID: 43063-758_d2bb8d09-196f-963a-e053-2a95a90a430c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2016-09-30
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 400 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-758		D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-30	D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-60	D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-83	D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-86	D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-90	D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-93	D	Discontinued by firm	2026-08-17
excluded package	package	43063-758	43063-758-94	D	Discontinued by firm	2026-08-17

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 · 96 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	43063-758-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-758-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-758-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-758-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-758-86	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-758-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-758-83	`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	43063-758-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-758-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-758-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-758-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-758-86	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-758-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-758-83	`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	43063-758-93	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-758-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-758-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-758-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-758-86	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-758-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-758-83	`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	43063-758-93	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-758-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-758-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-758-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-758-86	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-758-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-758-83	`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	43063-758-93	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-758-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-758-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-758-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-758-86	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-758-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-758-83	`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	43063-758-93	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-758-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-758-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-758-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-758-86	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-758-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-758-83	`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	43063-758-93	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-758-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-758-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-758-94	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-758-86	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-758-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-758-83	`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	43063-758-93	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-758-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-758-90	`ed331223b511…`	`672a5bd82f5f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 128 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
2026-08-18 06:07:40	2026-07	A204989-001	RELGAABI	100MG	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-002	RELGAABI	300MG	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-003	RELGAABI	400MG	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-004	RELGAABI	200MG	CAPSULE / ORAL	AB	2026-03-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204989-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-004	AB	1	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-758-30	EA - Each	43063-758	f3f21ad4-b76c-4adf-bb8f-bb759cfd0e2d	1	2017-06-15
43063-758-60	EA - Each	43063-758	ac324784-de41-42a6-bab7-e4acd8c74e32	1	2017-06-15
43063-758-83	EA - Each	43063-758	dad38c47-e698-472f-ba8d-371f4c9c5d5a	1	2017-06-15
43063-758-86	EA - Each	43063-758	907388a6-dd62-43a1-9f6b-109f0098c794	1	2017-06-15
43063-758-90	EA - Each	43063-758	14cb0857-1039-47d5-8212-a233258ed3ef	1	2017-06-15
43063-758-93	EA - Each	43063-758	b156c02b-1320-49a5-a00a-ef157fe18f6c	1	2017-06-15
43063-758-94	EA - Each	43063-758	5bf3ef4b-027d-4866-a162-644a0a2aa2cb	1	2017-06-15

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	Bryant Ranch Prepack	cb81fd89-b32b-4538-bf5c-ab02f65b3458	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	691205ba-fa65-4bc9-ba20-7d361382cff9	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	97e47698-97c9-4eb5-a108-5850c2aa2818	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2ac0622c-440a-49a0-974f-726e6ac72a0e	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	48037fc4-1aab-4ae8-aede-7c55b494877a	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-758-30	43063075830	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-30)	30 capsule	2017-04-25	0000-00-00	No	No	Current
43063-758-60	43063075860	60 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-60)	60 capsule	2017-04-25	0000-00-00	No	No	Current
43063-758-83	43063075883	540 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-83)	540 capsule	2017-04-25	0000-00-00	No	No	Current
43063-758-86	43063075886	360 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-86)	360 capsule	2017-04-25	0000-00-00	No	No	Current
43063-758-90	43063075890	90 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-90)	90 capsule	2017-04-25	0000-00-00	No	No	Current
43063-758-93	43063075893	180 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-93)	180 capsule	2017-04-25	0000-00-00	No	No	Current
43063-758-94	43063075894	270 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-94)	270 capsule	2017-04-25	0000-00-00	No	No	Current