Gabapentin

Product NDC
69367-133
Requested package NDC
69367-133-06
11-digit product format
693670133
Labeler code
69367
Product ID
69367-133_b779d072-7cc4-4fa2-9421-0e8ea96334cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-04-01
Marketing end
2026-12-01
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204989-001RELGAABI100MGCAPSULE / ORALAB2016-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A204989-002RELGAABI300MGCAPSULE / ORALAB2016-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A204989-003RELGAABI400MGCAPSULE / ORALAB2016-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A204989-004RELGAABI200MGCAPSULE / ORALAB2026-03-0684e616aacf4f…
2026-08-18 06:07:402026-07A204989-001RELGAABI100MGCAPSULE / ORALAB2016-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-002RELGAABI300MGCAPSULE / ORALAB2016-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-003RELGAABI400MGCAPSULE / ORALAB2016-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-004RELGAABI200MGCAPSULE / ORALAB2026-03-06caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204989-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204989-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204989-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A204989-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A204989-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-004AB1caaa826d4ba7…
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…

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310431Internal RxNorm lookup
310432Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f70c496-b58c-30f5-e054-00144ff8d46cAvailable 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
69367-133-04Gabapentin100 in 1 BOTTLECAPSULE10011
69367-133-06Gabapentin500 in 1 BOTTLECAPSULE50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-133-04EA - Each69367-133d3b3d085-d11f-4370-9e09-6557b0ed9a0e12016-09-02
69367-133-06EA - Each69367-1336539e15b-3eab-48a6-afb6-0618f306fe1712016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-133GABAPENTIN CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]10Current NDC, Legacy NDC, 2 package rows20250417_2f70c496-b58c-30f5-e054-00144ff8d46c.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 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.d35cd5ac-5ed6-2405-e053-2995a90a69462026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack1af098ad-28b5-463f-8efa-24d70a77d64c2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack9a2658d5-9b0e-4921-b4c5-4c89f1630d692026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack43cbff48-8219-41ba-b67d-3ae4544b78bb2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINTrifluent Pharma, LLC59442de1-7cf0-35f6-e063-6294a90a57d72026-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepackcb81fd89-b32b-4538-bf5c-ab02f65b34582026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack691205ba-fa65-4bc9-ba20-7d361382cff92026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack97e47698-97c9-4eb5-a108-5850c2aa28182026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack2ac0622c-440a-49a0-974f-726e6ac72a0e2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN2f70c496-b58c-30f5-e054-00144ff8d46c11
310431gabapentin 300 MG Oral CapsulePSN2f70c496-b58c-30f5-e054-00144ff8d46c11
310432gabapentin 400 MG Oral CapsulePSN2f70c496-b58c-30f5-e054-00144ff8d46c11
310430gabapentin 100 MG Oral CapsuleSCD2f70c496-b58c-30f5-e054-00144ff8d46c11
310431gabapentin 300 MG Oral CapsuleSCD2f70c496-b58c-30f5-e054-00144ff8d46c11
310432gabapentin 400 MG Oral CapsuleSCD2f70c496-b58c-30f5-e054-00144ff8d46c11
310430gabapentin 100 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310431gabapentin 300 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310430gabapentin 100 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310431gabapentin 300 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsulePSN22f2294f-352a-4515-87c8-a6ae46e613221
310432gabapentin 400 MG Oral CapsuleSCD22f2294f-352a-4515-87c8-a6ae46e613221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-133-0669367013306500 CAPSULE in 1 BOTTLE (69367-133-06) 500 capsule2016-04-012026-12-01NoNoCurrent