GABAPENTIN

Product NDC
51655-246
11-digit product format
516550246
Labeler code
51655
Product ID
51655-246_d3a1c3be-5b4c-45a3-a8ef-a103f337050d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA090705
Marketing category
ANDA
Marketing start
2014-12-23
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
2018-12-31
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 productproduct51655-246DDiscontinued by firm2026-08-11
excluded packagepackage51655-24651655-246-52DDiscontinued 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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-246-52DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-246-52DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-246-52DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-246-52DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-246-52DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-246-52DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-246-52DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-246-52DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-246-52DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-246-52DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-246-52DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-246-52DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-246-52IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-246-52IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-246-52IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-246-52IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-246-52IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-246-52IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-246-52IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-246-52IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-246-52EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

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
A090705-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2009-12-30
A090705-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2009-12-30
A090705-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2009-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090705-001AB
A090705-002AB
A090705-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090705-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-246-522024-05-14C16284748780-19d75b9d0-023b-f424-e053-dadaa90a57ceGABAPENTIN
51655-246-522020-01-31C16284748780-19d75b9d0-023b-f424-e053-dadaa90a57ceGABAPENTIN

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [NORTHWIND PHARMACEUTICALS]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [NORTHWIND PHARMACEUTICALS]1

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack6e7f602a-2c5f-4651-a228-5fc5bf2492052024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack1fd95278-842f-4bf9-abd5-4d9aa858d36d2024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack97a1d45d-d5b3-4be7-9b3a-cb6f80f602912024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP4bae5032-f634-4d1e-b672-8a7e2bd6a5fa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP92c4d589-533b-4fe4-833f-dd68cc1f7e662019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCa900bafb-8f49-4a01-ba7f-4fb228ec02532018-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC6702ed8f-4aaf-46fa-bf39-db75154aa44c2018-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705