GABAPENTIN

Product NDC
64725-0138
11-digit product format
647250138
Labeler code
64725
Product ID
64725-0138_dbba4900-cfca-4dd9-8241-b8a675ab6128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077242
Marketing category
ANDA
Marketing start
2006-08-24
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-0138IInactivated by FDA2026-10-05
excluded packagepackage64725-013864725-0138-1IInactivated by FDA2026-10-05

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 · 44 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 packagepackage64725-0138-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-0138-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-0138-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-0138-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-0138-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-0138-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-0138-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-0138-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-0138-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-0138-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-0138-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-0138-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-0138-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-0138-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-0138-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-0138-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-0138-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-0138-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-0138-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-0138-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-0138-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-0138-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077242-001GABAPENTINGABAPENTIN100MGCAPSULE / ORAL2006-08-24
A077242-002GABAPENTINGABAPENTIN300MGCAPSULE / ORAL2006-08-24
A077242-003GABAPENTINGABAPENTIN400MGCAPSULE / ORAL2006-08-24

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077242-002GABAPENTIN300MGCAPSULE / ORAL2006-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077242-003GABAPENTIN400MGCAPSULE / ORAL2006-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077242-001GABAPENTIN100MGCAPSULE / ORAL2006-08-24301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A077242-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077242-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077242-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077242-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077242-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077242-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077242-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077242-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077242-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077242-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077242-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077242-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077242-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077242-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077242-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077242-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077242-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077242-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077242-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077242-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077242-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077242-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077242-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077242-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077242-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077242-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077242-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077242-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077242-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077242-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077242-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077242-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077242-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077242-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077242-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077242-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077242-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077242-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077242-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077242-001AB1ea99ee380514…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0138-12019-11-27C16284748780-19855e2a2-4224-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0138-1GABAPENTIN60 in 1 BOTTLECAPSULE602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0138GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140902_249e184c-8996-4206-8ee3-b6faa46d3188.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINSun Pharmaceutical Industries, Inc.c9a05f0c-b5f0-422c-9d67-6d0efc921a742026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077242
application number: ANDA077242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN249e184c-8996-4206-8ee3-b6faa46d31882
310431gabapentin 300 MG Oral CapsuleSCD249e184c-8996-4206-8ee3-b6faa46d31882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0138-16472501380160 in 1 BOTTLEHistorical