Gabapentin

Product NDC: 10544-436
11-digit product format: 105440436
Labeler code: 10544
Product ID: 10544-436_a58e76e8-0645-4c40-a738-5015e88bd68c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA075360
Marketing category: ANDA
Marketing start: 2014-04-04
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-436		I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 3 · 144 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-81	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-436	10544-436-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	10544-436		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-436	10544-436-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-436	10544-436-84	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-436	10544-436-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-436	10544-436-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-436	10544-436-45	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`

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
A075360-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06
A075360-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06
A075360-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075360-001	AB
A075360-002	AB
A075360-003	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	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`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	A075360-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075360-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc	c681c804-c6f3-d63b-e053-2995a90a6b8f	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	3aaf3d6e-c6d5-89f5-e063-6394a90a9b77	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc.	b20ee34a-7f2d-4d62-a161-898565f74547	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	185f264e-db32-41cd-b90d-519717b97850	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-436-00	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-02	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-30	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-45	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-60	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-81	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-84	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-90	2019-11-27	C162847	48780-1	9855e2a2-358b-60a7-e053-dbdaa90a05bd	Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-436-00	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	2
10544-436-02	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	2
10544-436-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	2
10544-436-45	Gabapentin	45 in 1 BOTTLE	CAPSULE	45	2
10544-436-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	2
10544-436-81	Gabapentin	180 in 1 BOTTLE	CAPSULE	180	2
10544-436-84	Gabapentin	84 in 1 BOTTLE	CAPSULE	84	2
10544-436-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-436-00	EA - Each	10544-436	7d94fe9b-70ba-4d1f-bfa1-22f622b267b5	1	2015-10-02
10544-436-02	EA - Each	10544-436	b9bad236-fee5-45d6-94ab-8429600fe495	1	2014-07-02
10544-436-30	EA - Each	10544-436	3e242e1d-c593-4122-bd7c-b016fec0f8c5	1	2014-05-02
10544-436-45	EA - Each	10544-436	28dd0e79-1c3f-4ae0-aa7c-dd97589bc615	1	2015-10-02
10544-436-60	EA - Each	10544-436	75d303d0-4b3b-4dd3-bd8f-62e358517f18	1	2014-05-02
10544-436-81	EA - Each	10544-436	54591579-e2bf-4cce-a5c7-ca0fd5a1dcbb	1	2014-07-02
10544-436-84	EA - Each	10544-436	e3c370d2-d13c-41d7-a6c8-668d4dbe4502	1	2015-10-02
10544-436-90	EA - Each	10544-436	5b3755c1-a4ee-4e7b-a6a2-3fe6b7e9b2c1	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-436	GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 8 package rows	20140404_2550a291-51f6-473f-89cd-193bbe97662a.zip

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
310431	gabapentin 300 MG Oral Capsule	PSN	2550a291-51f6-473f-89cd-193bbe97662a	2
310432	gabapentin 400 MG Oral Capsule	PSN	2550a291-51f6-473f-89cd-193bbe97662a	2
310431	gabapentin 300 MG Oral Capsule	SCD	2550a291-51f6-473f-89cd-193bbe97662a	2
310432	gabapentin 400 MG Oral Capsule	SCD	2550a291-51f6-473f-89cd-193bbe97662a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-436-00	10544043600	100 in 1 BOTTLE	Historical
10544-436-02	10544043602	120 in 1 BOTTLE	Historical
10544-436-30	10544043630	30 in 1 BOTTLE	Historical
10544-436-45	10544043645	45 in 1 BOTTLE	Historical
10544-436-60	10544043660	60 in 1 BOTTLE	Historical
10544-436-81	10544043681	180 in 1 BOTTLE	Historical
10544-436-84	10544043684	84 in 1 BOTTLE	Historical
10544-436-90	10544043690	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg	Blenheim Pharmacal, Inc.	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	2