GABAPENTIN

Product NDC: 53002-1472
11-digit product format: 530021472
Labeler code: 53002
Product ID: 53002-1472_8695619f-99fd-4255-9a1f-a722284b334c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090705
Marketing category: ANDA
Marketing start: 2016-06-29
Marketing end: 0000-00-00
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-1472		I	Inactivated by FDA	2026-08-11
excluded package	package	53002-1472	53002-1472-0	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-1472	53002-1472-3	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-1472	53002-1472-6	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 · 48 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	53002-1472-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1472-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1472-3	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	53002-1472-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1472-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1472-3	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	53002-1472-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1472-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1472-3	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	53002-1472-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1472-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1472-3	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	53002-1472-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1472-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1472-3	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	53002-1472-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1472-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1472-3	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	53002-1472-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1472-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1472-0	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	53002-1472-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1472-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1472-0	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	53002-1472-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1472-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1472-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1472-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1472-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1472-6	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1472-6	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1472-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1472-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53002-1472-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53002-1472-6	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53002-1472-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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	TE codes	Approval date
A090705-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30
A090705-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30
A090705-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090705-001	AB
A090705-002	AB
A090705-003	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 · 123 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	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2009-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2009-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090705-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2009-12-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090705-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090705-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090705-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090705-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090705-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090705-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090705-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090705-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090705-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090705-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090705-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090705-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090705-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090705-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090705-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090705-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090705-001	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
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1472-0	2025-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-3	2025-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-6	2025-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-0	2023-06-07	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-3	2023-06-07	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-6	2023-06-07	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-0	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-3	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-6	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-0	2020-12-15	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-3	2020-12-15	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-6	2020-12-15	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-0	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-3	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
53002-1472-6	2020-01-31	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1472-0	GABAPENTIN	100 in 1 BOTTLE	CAPSULE	100	9
53002-1472-3	GABAPENTIN	30 in 1 BOTTLE	CAPSULE	30	9
53002-1472-6	GABAPENTIN	60 in 1 BOTTLE	CAPSULE	60	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1472	GABAPENTIN CAPSULE [RPK PHARMACEUTICALS, INC.]	9	Legacy NDC, 3 package rows	20230609_783af1df-dbcc-41c9-bbd6-fcb3d2838153.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	1373587e-807a-462a-bff6-8a7113ce9f0a	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	41d1ead3-046e-4abf-ae0a-cb126a1f5848	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Cipla USA Inc.	9e4eca9c-6a2c-4ede-a252-1a27094bf594	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	6e7f602a-2c5f-4651-a228-5fc5bf249205	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	1fd95278-842f-4bf9-abd5-4d9aa858d36d	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	97a1d45d-d5b3-4be7-9b3a-cb6f80f60291	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	45039bba-7a96-450c-95be-83a3aa4fcbd2	2020-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Proficient Rx LP	4bae5032-f634-4d1e-b672-8a7e2bd6a5fa	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Proficient Rx LP	92c4d589-533b-4fe4-833f-dd68cc1f7e66	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	a900bafb-8f49-4a01-ba7f-4fb228ec0253	2018-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6702ed8f-4aaf-46fa-bf39-db75154aa44c	2018-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090705 application number: ANDA090705

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	783af1df-dbcc-41c9-bbd6-fcb3d2838153	9
310431	gabapentin 300 MG Oral Capsule	PSN	783af1df-dbcc-41c9-bbd6-fcb3d2838153	9
310430	gabapentin 100 MG Oral Capsule	SCD	783af1df-dbcc-41c9-bbd6-fcb3d2838153	9
310431	gabapentin 300 MG Oral Capsule	SCD	783af1df-dbcc-41c9-bbd6-fcb3d2838153	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1472-0	53002147200	100 CAPSULE in 1 BOTTLE (53002-1472-0)	100 capsule	2017-09-01	0000-00-00	No	No	Current
53002-1472-3	53002147203	30 CAPSULE in 1 BOTTLE (53002-1472-3)	30 capsule	2017-09-01	0000-00-00	No	No	Current
53002-1472-6	53002147206	60 CAPSULE in 1 BOTTLE (53002-1472-6)	60 capsule	2017-09-01	0000-00-00	No	No	Current