Gabapentin

Product NDC
70518-0810
Requested package NDC
70518-0810-2
11-digit product format
705180810
Labeler code
70518
Product ID
70518-0810_e26e073b-5645-3670-e053-2a95a90a8ab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203244
Marketing category
ANDA
Marketing start
2017-10-30
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
2023-12-31
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 packagepackage70518-081070518-0810-2DDiscontinued 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 · 15 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 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…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 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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

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
A203244-001GABAPENTINGABAPENTIN800MGTABLET / ORALAB12013-07-12
A203244-002GABAPENTINGABAPENTIN600MGTABLET / ORALAB12013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203244-001AB1
A203244-002AB1

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203244-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203244-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203244-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203244-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203244-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203244-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203244-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203244-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203244-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203244-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203244-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203244-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203244-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203244-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203244-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203244-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203244-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203244-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-0810-02025-08-15These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
70518-0810-12025-08-15These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
70518-0810-22025-08-15These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
70518-0810-02024-01-30These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
70518-0810-12024-01-30These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
70518-0810-22024-01-30These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0810GABAPENTIN TABLET, FILM COATED [REMEDYREPACK INC.]9Legacy NDC20220628_8ededc3f-bf92-463d-bf89-ef10e38639a9.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.07c8bb17-9bd4-4fab-994d-0412205b53b42026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepackb6db5ce9-bd4b-420d-88a7-df9d46144c812026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINStrides Pharma Science Limitedbec31452-b52b-4698-ba4c-0b614780ee842025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy7d3fc163-25f0-2c61-e053-2991aa0a76e92025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb2024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack47f2a06f-4eac-4dca-aa2a-a36dd4daaea02024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepackb4954172-5439-48fd-8348-8a2e0d2fee622024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepackc9944562-563a-423d-972c-f0313375d2342024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack56967a93-b3c0-4043-9241-585fc64e26242023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack0eb27e64-1488-4083-82c7-cebb8c0605de2023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINACI Healthcare USA, Inc.d7646d5e-ca25-4ec5-9e4b-931edcb15a0e2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC39149f0e-30ed-4671-8be7-2a484f65d63b2020-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINProficient Rx LP8b2f38ef-0a0c-45cc-88ca-cc086bf806412020-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCba2a8352-5776-4edb-914e-ce1d18ccda322020-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINProficient Rx LPc09c66fd-cb31-41dd-b00b-acc58bd809f72020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0810-270518081002180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0810-2) 2018-01-220000-00-00NoNoCurrent