Gabapentin

Product NDC
45865-356
Requested package NDC
45865-356-51
11-digit product format
458650356
Labeler code
45865
Product ID
45865-356_9700d830-6f75-d9c6-e053-2a95a90ab4f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
Marketing end
0000-00-00
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45865-35645865-356-51IInactivated by FDA2026-08-17

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 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077662-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12006-08-18
A077662-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12006-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077662-001AB1
A077662-002AB1

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077662-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077662-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-356-30Gabapentin30 in 1 BOTTLETABLET306
45865-356-49Gabapentin100 in 1 BOTTLETABLET1006
45865-356-51Gabapentin120 in 1 BOTTLETABLET1206
45865-356-60Gabapentin60 in 1 BOTTLETABLET606
45865-356-90Gabapentin90 in 1 BOTTLETABLET906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-356GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]6Legacy NDC, 5 package rows20191111_1d382246-eec8-69cc-e054-00144ff8d46c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINUnit Dose Solutions, Inc.54edd6f3-06c7-a0c7-e063-6394a90a8b4f2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack4cb26d6e-7963-4fe5-903e-ab51805450662026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack2278ce1b-1c19-4ad2-89c6-4530f7b78ea72025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.7c3b232a-3e9f-4249-9e5a-295482ee288a2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINProficient Rx LPc78f528f-9192-4037-bfb9-ff5718ed26c52019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN1d382246-eec8-69cc-e054-00144ff8d46c6
310433gabapentin 600 MG Oral TabletSCD1d382246-eec8-69cc-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-356-5145865035651120 TABLET in 1 BOTTLE (45865-356-51) 120 tablet2015-08-140000-00-00NoNoCurrent