Gabapentin

Product NDC
67877-428
11-digit product format
678770428
Labeler code
67877
Product ID
67877-428_280c139f-c3a2-46e4-b990-ce3808166e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA206402
Marketing category
ANDA
Marketing start
2015-11-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A206402-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12015-12-23
A206402-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12015-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206402-001AB1
A206402-002AB1

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 UTC2026-02A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206402-001GABAPENTIN600MGTABLET / ORALAB12015-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206402-002GABAPENTIN800MGTABLET / ORALAB12015-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206402-001GABAPENTIN600MGTABLET / ORALAB2015-12-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206402-002GABAPENTIN800MGTABLET / ORALAB2015-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206402-001GABAPENTIN600MGTABLET / ORALAB2015-12-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206402-002GABAPENTIN800MGTABLET / ORALAB2015-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206402-001GABAPENTIN600MGTABLET / ORALAB2015-12-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206402-002GABAPENTIN800MGTABLET / ORALAB2015-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206402-001GABAPENTIN600MGTABLET / ORALAB2015-12-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206402-002GABAPENTIN800MGTABLET / ORALAB2015-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206402-001GABAPENTIN600MGTABLET / ORALAB2015-12-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206402-002GABAPENTIN800MGTABLET / ORALAB2015-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206402-001GABAPENTIN600MGTABLET / ORALAB2015-12-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A206402-002GABAPENTIN800MGTABLET / ORALAB2015-12-23782e0a99824c…

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 UTC2026-02A206402-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206402-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206402-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206402-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206402-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206402-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206402-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206402-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206402-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206402-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206402-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206402-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206402-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206402-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206402-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206402-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206402-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206402-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206402-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A206402-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206402-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206402-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206402-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206402-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206402-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206402-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206402-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206402-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206402-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206402-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206402-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206402-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206402-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206402-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206402-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206402-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206402-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206402-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206402-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206402-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310433Internal RxNorm lookup
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d445d1d-02d1-4a59-b3b2-9ba5cd924c9aAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-428-01Gabapentin100 in 1 BOTTLETABLET10030
67877-428-05Gabapentin500 in 1 BOTTLETABLET50030
67877-428-10Gabapentin1000 in 1 BOTTLETABLET100030
67877-428-38Gabapentin10 in 1 BLISTER PACKTABLET1030
67877-428-38Gabapentin100 in 1 CARTONTABLET10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-428-01EA - Each67877-428345d2f1d-eca8-4bd1-ad15-74ae9e0a04ac12016-11-08
67877-428-05EA - Each67877-4286ec154a4-de7d-4e30-b9fa-04414f8d769b12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-428GABAPENTIN TABLET [ASCEND LABORATORIES, LLC]30Current NDC, Legacy NDC, 5 package rows20250504_4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.81243958-cc5a-4ec0-a64d-71682f949d5f2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINREMEDYREPACK INC.bc525ae4-9843-4038-a1b7-0d3543e2282c2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINNuCare Pharmaceuticals, Inc.57383d2a-d2c7-bbdc-e063-6294a90ada982026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINBryant Ranch Prepack172776c0-909e-49ce-bfe1-cf154a9458ba2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINBryant Ranch Prepackdf9c7c84-a8d9-4da8-babe-c55c9420d4e62026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINBryant Ranch Prepack72729513-bd34-44f5-9f62-297ed25c44422026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINBryant Ranch Prepackf31172a2-0ae9-49f2-b797-b26fe33f3f642026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINAscend Laboratories, LLC4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
ndc (product): 67877-428
GabapentinGABAPENTINDirect_Rx30a2ed14-dcda-f972-e063-6294a90a417c2025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINBryant Ranch Prepacka1ff94a9-69c4-486a-aab2-563c7ed244c82025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91ca-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206402
application number: ANDA206402

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNdf9c7c84-a8d9-4da8-babe-c55c9420d4e6110
310433gabapentin 600 MG Oral TabletSCDdf9c7c84-a8d9-4da8-babe-c55c9420d4e6110
310433gabapentin 600 MG Oral TabletPSN72729513-bd34-44f5-9f62-297ed25c4442102
310433gabapentin 600 MG Oral TabletSCD72729513-bd34-44f5-9f62-297ed25c4442102
310433gabapentin 600 MG Oral TabletPSN4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a30
310434gabapentin 800 MG Oral TabletPSN4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a30
310433gabapentin 600 MG Oral TabletSCD4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a30
310434gabapentin 800 MG Oral TabletSCD4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a30
310433gabapentin 600 MG Oral TabletPSNa1ff94a9-69c4-486a-aab2-563c7ed244c813
310433gabapentin 600 MG Oral TabletSCDa1ff94a9-69c4-486a-aab2-563c7ed244c813
310433gabapentin 600 MG Oral TabletPSN81243958-cc5a-4ec0-a64d-71682f949d5f11
310433gabapentin 600 MG Oral TabletSCD81243958-cc5a-4ec0-a64d-71682f949d5f11
310433gabapentin 600 MG Oral TabletPSN2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d2
310434gabapentin 800 MG Oral TabletPSN2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d2
310433gabapentin 600 MG Oral TabletSCD2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d2
310434gabapentin 800 MG Oral TabletSCD2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-428-0167877042801100 TABLET in 1 BOTTLE (67877-428-01) 100 tablet2015-11-010000-00-00NoNoCurrent
67877-428-0567877042805500 TABLET in 1 BOTTLE (67877-428-05) 500 tablet2015-11-010000-00-00NoNoCurrent
67877-428-10678770428101000 TABLET in 1 BOTTLE (67877-428-10) 1000 tablet2015-11-010000-00-00NoNoCurrent
67877-428-3867877042838100 BLISTER PACK in 1 CARTON (67877-428-38) / 10 TABLET in 1 BLISTER PACK100 blister pack2015-11-010000-00-00NoNoCurrent