Gabapentin

Product NDC
68788-7848
11-digit product format
687887848
Labeler code
68788
Product ID
68788-7848_f67d9eb0-b6cd-45b7-8ce0-96a85c30d1c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2021-01-22
Substance
GABAPENTIN
Active strength
300 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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 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
310431Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bff3beea-1f05-4e84-bcd2-d05782acddaeAvailable 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
68788-7848-0Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1004
68788-7848-1Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE1804
68788-7848-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE304
68788-7848-5Gabapentin15 in 1 BOTTLE, PLASTICCAPSULE154
68788-7848-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE604
68788-7848-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1204
68788-7848-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7848-0EA - Each68788-7848793cf1e1-7786-4213-9905-c0a4460db28312021-03-02
68788-7848-1EA - Each68788-78484bf747aa-bba8-49ea-9f05-700a8485b68a12021-03-02
68788-7848-3EA - Each68788-784839699adc-eb3d-47b0-98af-0bbb2a19a2cd12021-03-02
68788-7848-5EA - Each68788-7848f4ff6de4-60f7-4df3-aea1-5e6d2b4f749312021-03-02
68788-7848-6EA - Each68788-784896425a0b-faa9-4db1-b8a3-9cf26c88e4f812021-03-02
68788-7848-8EA - Each68788-78489fdc304b-7942-4d30-a0c3-437be0c321af12021-03-02
68788-7848-9EA - Each68788-78483e371f6e-82db-4d1e-8751-64f3559d2a3b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7848GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 7 package rows20240112_bff3beea-1f05-4e84-bcd2-d05782acddae.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
310431gabapentin 300 MG Oral CapsulePSNbff3beea-1f05-4e84-bcd2-d05782acddae4
310431gabapentin 300 MG Oral CapsuleSCDbff3beea-1f05-4e84-bcd2-d05782acddae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7848-068788784800100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-0) 100 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-168788784801180 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-1) 180 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-36878878480330 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-3) 30 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-56878878480515 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-5) 15 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-66878878480660 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-6) 60 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-868788784808120 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-8) 120 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-96878878480990 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-9) 90 capsule2021-01-220000-00-00NoNoCurrent