Gabapentin

Product NDC
63629-6791
Requested package NDC
63629-6791-1
11-digit product format
636296791
Labeler code
63629
Product ID
63629-6791_1e027c7f-f3e1-4898-8ad3-5bddd8a7d29e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 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 packagepackage63629-679163629-6791-1DDiscontinued by firm2026-08-17

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 · 13 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 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078787-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2008-01-31
A078787-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2008-01-31
A078787-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078787-001AB
A078787-002AB
A078787-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-311e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078787-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078787-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078787-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078787-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078787-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078787-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINRedpharm Drug58474aa7-7c6a-3a94-e063-6394a90a870b2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINREMEDYREPACK INC.6beed8eb-446c-4575-8dc8-b798623d92c72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepack912d8697-b466-48dc-88d3-d2ba90e766442026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutions3dbd447f-4791-4c62-86b4-6f79288627852026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutions67330eef-c976-4862-b1ae-20f30f43df762026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackefb86e22-5a84-4b33-aad0-71dd5a2c6c8f2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackeaf5e41e-8ed3-404e-84e0-392bebdbc0b72025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepack344d67fa-092e-4e71-b96a-25c71bfa6bb12025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackbc1316b6-1fc4-4990-95a8-4898817728762025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINNorthStar Rx LLCf7c1fd34-d615-43a2-8989-898fe11f90df2025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutionsd25daaac-a8ab-4f12-acc2-4ec8fc97a2d42025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAurobindo Pharma Limited1a619a14-0b63-4cba-80e7-474c9a1c90b92025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb33c18ea-554d-3cfb-e053-2a95a90a2dd12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCbc08e35d-ef5d-1dcd-e053-2a95a90ab5de2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackff28c5f1-da56-4072-a6fa-d689d4a6761b2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBoswell Pharmacy Services LLC d/b/a BPS Wholesale1e28ad3d-2d34-a5d0-e063-6294a90adb9e2024-07-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutionsecb798a0-377d-4712-bb82-ec9d7116962f2023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC3b4395f2-9440-4b67-97cc-5d16f3bdd05e2020-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINProficient Rx LPded42b88-94dd-462d-bcdf-7fd34d1e49c32020-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINProficient Rx LP7d77dae0-df76-4b7b-9690-713e9a60e3cd2019-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6791-16362967910160 CAPSULE in 1 BOTTLE (63629-6791-1) 60 capsule2015-09-220000-00-00NoNoCurrent