Gabapentin

Product NDC
10135-648
Requested package NDC
10135-648-01
11-digit product format
101350648
Labeler code
10135
Product ID
10135-648_d178699e-2910-b747-e053-2a95a90a9de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA205101
Marketing category
ANDA
Marketing start
2018-04-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10135-64810135-648-01IInactivated by FDA2026-10-15

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 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205101-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12016-02-04
A205101-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12016-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205101-001AB1
A205101-002AB1

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04c2088c7a36db…
2026-10-15 13:18:302026-09A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04c2088c7a36db…
2026-09-14 22:38:342026-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0484e616aacf4f…
2026-09-14 22:38:342026-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0484e616aacf4f…
2026-08-18 06:07:402026-07A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-044b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A205101-001AB11c2088c7a36db…
2026-10-15 13:18:302026-09A205101-002AB11c2088c7a36db…
2026-09-14 22:38:342026-08A205101-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A205101-002AB1184e616aacf4f…
2026-08-18 06:07:402026-07A205101-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A205101-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205101-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205101-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205101-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205101-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205101-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A205101-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205101-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205101-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205101-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205101-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205101-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205101-002AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10135-648-012023-01-30These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93
10135-648-052023-01-30These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93
10135-648-012021-11-23These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93
10135-648-052021-11-23These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93
10135-648-012020-01-31These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93
10135-648-052020-01-31These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-648-01Gabapentin100 in 1 BOTTLETABLET1003
10135-648-05Gabapentin500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-648-01EA - Each10135-648078abceb-2926-498b-b1f2-a6e305a36c5912018-05-09
10135-648-05EA - Each10135-6488ec7acf5-7d94-44cf-923b-c9fafdd9fc5212018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-648GABAPENTIN TABLET [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20211124_e28c6b45-4624-4c48-95e7-cb2d2404f70b.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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC7a2aa696-7dac-4d03-916a-374b61a255b52024-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC79cd9dea-e7d0-44db-afba-964cb99f32b62024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf9bf87e4-5499-4dd7-a0c1-16025a718d142024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINProficient Rx LP9c96b488-19bd-431e-af9a-b313ffd9eaae2023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCaf62bb7e-162e-4e2a-8eb0-d50f666787072023-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINProficient Rx LP35004f84-90ae-45f0-a2ba-653dec5072292023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINAsclemed USA, Inc.9d544944-ea95-42e1-8c65-9e442437f0ee2022-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINAsclemed USA, Inc.c18d9d06-f796-4eb7-8fd5-1de4ebb954392022-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINProficient Rx LPb67b7865-df64-429a-9550-5333b9c713ea2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINProficient Rx LP2fb2233f-9152-4630-ab39-51a0cda7e5ca2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINProficient Rx LP2b76955c-52a4-4026-b286-3da1112fe9892022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNe28c6b45-4624-4c48-95e7-cb2d2404f70b3
310434gabapentin 800 MG Oral TabletPSNe28c6b45-4624-4c48-95e7-cb2d2404f70b3
310433gabapentin 600 MG Oral TabletSCDe28c6b45-4624-4c48-95e7-cb2d2404f70b3
310434gabapentin 800 MG Oral TabletSCDe28c6b45-4624-4c48-95e7-cb2d2404f70b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-648-0110135064801100 TABLET in 1 BOTTLE (10135-648-01) 100 tablet2018-04-010000-00-00NoNoCurrent