Gabapentin

Product NDC
71335-1484
Requested package NDC
71335-1484-1
11-digit product format
713351484
Labeler code
71335
Product ID
71335-1484_a8a8b736-629f-41bb-b381-2bfa8780a5c6
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
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3184e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078787-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078787-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078787-003AB184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
912d8697-b466-48dc-88d3-d2ba90e76644Available 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
71335-1484-1Gabapentin90 in 1 BOTTLECAPSULE904
71335-1484-2Gabapentin28 in 1 BOTTLECAPSULE284
71335-1484-3Gabapentin30 in 1 BOTTLECAPSULE304
71335-1484-4Gabapentin60 in 1 BOTTLECAPSULE604
71335-1484-5Gabapentin120 in 1 BOTTLECAPSULE1204
71335-1484-6Gabapentin84 in 1 BOTTLECAPSULE844

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
ndc (package): 71335-1484-1
ndc (product): 71335-1484
ndc11 (package): 71335148401
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN912d8697-b466-48dc-88d3-d2ba90e766444
310430gabapentin 100 MG Oral CapsuleSCD912d8697-b466-48dc-88d3-d2ba90e766444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1484-17133514840190 CAPSULE in 1 BOTTLE (71335-1484-1) 90 capsule2019-01-240000-00-00NoNoCurrent