Gabapentin

Product NDC
51407-047
Requested package NDC
51407-047-90
11-digit product format
514070047
Labeler code
51407
Product ID
51407-047_4aa8dcd6-952c-bebb-e063-6294a90af962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
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

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 packagepackage51407-04751407-047-90DDiscontinued by firm2026-08-11

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204989-001RELGAABIGABAPENTIN100MGCAPSULE / ORALAB2016-02-18
A204989-002RELGAABIGABAPENTIN300MGCAPSULE / ORALAB2016-02-18
A204989-003RELGAABIGABAPENTIN400MGCAPSULE / ORALAB2016-02-18
A204989-004RELGAABIGABAPENTIN200MGCAPSULE / ORALAB2026-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204989-001AB
A204989-002AB
A204989-003AB
A204989-004AB

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 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204989-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204989-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204989-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204989-001AB18072bd15b7f6…

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
51407-047-10Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100011
51407-047-18Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE18011
51407-047-27Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE27011
51407-047-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-047-10EA - Each51407-04772dc3699-123f-4233-990d-9c0206bcb3a312018-11-06
51407-047-18EA - Each51407-0475f6c93be-0145-4cd7-ae44-7090db73a71c12018-11-06
51407-047-27EA - Each51407-047814dc6a6-c6fb-4de4-b604-1890938482ca12018-11-06
51407-047-90EA - Each51407-04774fa51d1-baa1-42aa-b2d4-46604d496cf012018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-047GABAPENTIN CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 4 package rows20231227_76f5eff8-698f-2753-e053-2991aa0ae7f9.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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.e877a425-2b7f-4e43-a1f9-24019cbf96852026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.16542ee6-0e0e-4d3c-8b32-60ff6ef488462026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINHAWAII REPACK, INC.dd7adad2-e2f5-4b43-90a4-522bce0be5b32026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINNorthwind Health Company, LLC1b44a3ab-4d06-205f-e063-6294a90af3682026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINAsclemed USA, Inc.9a829dc3-b2d8-4d19-a579-0597217cec9b2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb7a29b99-ce23-950e-e053-2995a90a19342026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack4c49d34d-bb47-406b-8f2d-b4834b2ee9d02026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINCoupler LLC5385e27c-f2fa-32d5-e063-6294a90a0a8c2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINDirect_Rxf8998c1c-c359-6f01-e053-6294a90aebf42026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb8b7e045-a7fe-8539-e053-2a95a90a40f82026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.100ff86c-56a8-4770-9db3-b9bc6b1bd2f72026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.e3429322-c442-4146-bb68-bcc3a8d015522026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.2625c0ef-5295-41de-9e81-88001a6cbecc2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.41dcc917-68d1-49f0-8223-44c21ca259ef2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINCoupler LLC5073abda-321f-29d1-e063-6394a90a59ac2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPHOENIX RX LLC4f95c01f-200e-bfd7-e063-6394a90abc382026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepackcb81fd89-b32b-4538-bf5c-ab02f65b34582026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack2ac0622c-440a-49a0-974f-726e6ac72a0e2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN76f5eff8-698f-2753-e053-2991aa0ae7f912
310431gabapentin 300 MG Oral CapsulePSN76f5eff8-698f-2753-e053-2991aa0ae7f912
310432gabapentin 400 MG Oral CapsulePSN76f5eff8-698f-2753-e053-2991aa0ae7f912
310430gabapentin 100 MG Oral CapsuleSCD76f5eff8-698f-2753-e053-2991aa0ae7f912
310431gabapentin 300 MG Oral CapsuleSCD76f5eff8-698f-2753-e053-2991aa0ae7f912
310432gabapentin 400 MG Oral CapsuleSCD76f5eff8-698f-2753-e053-2991aa0ae7f912
310430gabapentin 100 MG Oral CapsulePSN20e48004-d8b6-40fd-929b-b95087b4d85d7
310430gabapentin 100 MG Oral CapsuleSCD20e48004-d8b6-40fd-929b-b95087b4d85d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-047-905140700479090 CAPSULE in 1 BOTTLE, PLASTIC (51407-047-90) 90 capsule2018-09-120000-00-00NoNoCurrent