Gabapentin

Product NDC
45865-122
Requested package NDC
45865-122-90
11-digit product format
458650122
Labeler code
45865
Product ID
45865-122_b2757fb9-1777-f115-e053-2995a90acddf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
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
2021-12-31
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 packagepackage45865-12245865-122-90IInactivated by FDA2026-08-11

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 · 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 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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-122-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED301
45865-122-51Gabapentin120 in 1 BOTTLETABLET, FILM COATED1201
45865-122-60Gabapentin60 in 1 BOTTLETABLET, FILM COATED601
45865-122-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-122GABAPENTIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 4 package rows20201025_b2757fb9-1776-f115-e053-2995a90acddf.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNb2757fb9-1776-f115-e053-2995a90acddf1
310433gabapentin 600 MG Oral TabletSCDb2757fb9-1776-f115-e053-2995a90acddf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-122-904586501229090 TABLET, FILM COATED in 1 BOTTLE (45865-122-90) 2014-01-110000-00-00NoNoCurrent