Gabapentin

Product NDC
0093-4443
11-digit product format
000934443
Labeler code
0093
Product ID
0093-4443_76e073b2-ef68-479a-938e-417338fc4105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076017
Marketing category
ANDA
Marketing start
2008-07-11
Marketing end
2019-05-31
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-4443DDiscontinued by firm2026-08-11
excluded packagepackage0093-44430093-4443-01DDiscontinued by firm2026-08-11
excluded packagepackage0093-44430093-4443-05DDiscontinued by firm2026-08-11
excluded packagepackage0093-44430093-4443-10DDiscontinued by firm2026-08-11

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-4443-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-4443-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-4443-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-4443-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-4443-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-4443-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-4443-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-4443-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-4443-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-4443-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-4443-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-4443-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-4443-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-4443-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-4443-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-4443-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-4443-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-4443-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-4443-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-4443-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-4443-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-4443-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-4443-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-4443-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-4443-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-4443-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-4443-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-4443-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-4443-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-4443-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-4443-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-4443-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-4443-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-4443-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-4443-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-4443-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076017-001GABAPENTINGABAPENTIN100MGTABLET / ORALAB12004-04-28
A076017-002GABAPENTINGABAPENTIN300MGTABLET / ORAL2004-04-28
A076017-003GABAPENTINGABAPENTIN400MGTABLET / ORALAB12004-04-28
A076017-004GABAPENTINGABAPENTIN600MGTABLET / ORAL2005-04-29
A076017-005GABAPENTINGABAPENTIN800MGTABLET / ORAL2005-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076017-001AB1
A076017-003AB1

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076017-002GABAPENTIN300MGTABLET / ORAL2004-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-002GABAPENTIN300MGTABLET / ORAL2004-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076017-002GABAPENTIN300MGTABLET / ORAL2004-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-002GABAPENTIN300MGTABLET / ORALAB12004-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-002GABAPENTIN300MGTABLET / ORALAB12004-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-002GABAPENTIN300MGTABLET / ORALAB12004-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-002GABAPENTIN300MGTABLET / ORALAB12004-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-001GABAPENTIN100MGTABLET / ORALAB12004-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-002GABAPENTIN300MGTABLET / ORALAB12004-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-003GABAPENTIN400MGTABLET / ORALAB12004-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-004GABAPENTIN600MGTABLET / ORAL2005-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-005GABAPENTIN800MGTABLET / ORAL2005-04-295bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 121 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076017-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076017-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076017-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076017-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076017-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076017-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076017-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076017-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076017-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076017-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076017-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076017-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076017-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076017-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076017-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076017-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076017-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076017-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076017-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076017-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076017-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076017-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076017-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076017-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076017-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076017-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076017-002AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076017-003AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076017-001AB15c6f7cd8ea54…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4443-01EA - Each0093-4443ef0a706a-a8b3-427b-bd7c-ac99cc13d9a112012-07-24
0093-4443-05EA - Each0093-444347796a19-8ab1-47b8-8526-cf5dc16e781112012-07-24
0093-4443-10EA - Each0093-44431a1dbfc1-97a5-4b1f-9f05-d98e9afbc70b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [STAT RX USA LLC]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAPENTIN TABLET [STAT RX USA LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAPENTIN TABLET [STAT RX USA LLC]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [STAT RX USA LLC]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN998dcd24-c6f0-463c-9d13-e5c72b0e8fa03
310433gabapentin 600 MG Oral TabletSCD998dcd24-c6f0-463c-9d13-e5c72b0e8fa03