Gabapentin

Product NDC
69367-347
11-digit product format
693670347
Labeler code
69367
Product ID
69367-347_3855844f-e123-4574-8d9b-76397d602744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA207057
Marketing category
ANDA
Marketing start
2021-11-01
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207057-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12017-10-26
A207057-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12017-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207057-001AB1
A207057-002AB1

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207057-001GABAPENTIN600MGTABLET / ORALAB12017-10-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207057-002GABAPENTIN800MGTABLET / ORALAB12017-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207057-001GABAPENTIN600MGTABLET / ORALAB2017-10-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207057-002GABAPENTIN800MGTABLET / ORALAB2017-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207057-001GABAPENTIN600MGTABLET / ORALAB2017-10-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207057-002GABAPENTIN800MGTABLET / ORALAB2017-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207057-001GABAPENTIN600MGTABLET / ORALAB2017-10-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207057-002GABAPENTIN800MGTABLET / ORALAB2017-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207057-001GABAPENTIN600MGTABLET / ORALAB2017-10-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207057-002GABAPENTIN800MGTABLET / ORALAB2017-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207057-001GABAPENTIN600MGTABLET / ORALAB2017-10-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207057-002GABAPENTIN800MGTABLET / ORALAB2017-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207057-001GABAPENTIN600MGTABLET / ORALAB2017-10-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A207057-002GABAPENTIN800MGTABLET / ORALAB2017-10-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207057-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207057-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207057-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207057-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207057-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207057-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207057-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207057-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207057-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207057-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207057-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207057-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207057-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207057-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207057-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207057-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207057-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207057-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207057-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207057-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207057-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207057-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207057-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207057-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207057-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207057-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207057-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207057-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207057-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207057-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207057-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207057-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207057-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207057-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207057-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207057-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207057-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207057-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207057-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207057-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310433Internal RxNorm lookup
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2eec52a1-9016-46dd-8b4c-8dab1d0aeeceAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-347-05Gabapentin500 in 1 BOTTLE, PLASTICTABLET, COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-347-05EA - Each69367-3476f3b21a8-66f8-4f97-b79c-5193a7a3a53612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-347GABAPENTIN TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20241225_2eec52a1-9016-46dd-8b4c-8dab1d0aeece.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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINTAGI Pharma, Inc.725878fa-1e2f-4fee-a9e1-a6e102c796252026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINBryant Ranch Prepackd8604417-9d43-4d27-a7ce-d4120ff201f42026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINA-S Medication Solutionsb88b0cbc-c883-4d17-8f46-0e5bddc578352026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINA-S Medication Solutions081fd1de-acaa-4685-a053-4959d77b17e92026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINPrecision Dose, Inc.021329d0-7d32-4fd8-81bf-a8b0d8b49e432025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINA-S Medication Solutionsb74a427c-9cc1-4b15-9ed2-cc891741fe672025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINMullan Pharmaceutical Inc.47a22de2-ec66-45be-8648-89ed3ab6e67e2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINPrecision Dose, Inc.86c93d8b-6286-44e2-93dd-f1b10a5d83da2025-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINProficient Rx LP87b9171b-7d00-40fa-87ff-a717740efe8a2025-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINProficient Rx LP0ad67a07-59d0-4aaa-906b-befbbad8af312025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.07871ab8-254b-e3c2-e063-6294a90a29ab2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINNuCare Pharmaceuticals, Inc.2c65253d-ca49-70eb-e063-6394a90a3cd22025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINAvPAKfaa47fcd-2545-a946-e053-6294a90a05d22025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCec1a01fe-5531-21df-e053-2a95a90a05612024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
GabapentinGABAPENTINWestminster Pharmaceuticals, LLC2eec52a1-9016-46dd-8b4c-8dab1d0aeece2024-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207057
application number: ANDA207057
ndc (product): 69367-347

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNec1a01fe-5531-21df-e053-2a95a90a05619
310434gabapentin 800 MG Oral TabletPSNec1a01fe-5531-21df-e053-2a95a90a05619
310433gabapentin 600 MG Oral TabletSCDec1a01fe-5531-21df-e053-2a95a90a05619
310434gabapentin 800 MG Oral TabletSCDec1a01fe-5531-21df-e053-2a95a90a05619
310433gabapentin 600 MG Oral TabletPSN2eec52a1-9016-46dd-8b4c-8dab1d0aeece4
310434gabapentin 800 MG Oral TabletPSN2eec52a1-9016-46dd-8b4c-8dab1d0aeece4
310433gabapentin 600 MG Oral TabletSCD2eec52a1-9016-46dd-8b4c-8dab1d0aeece4
310434gabapentin 800 MG Oral TabletSCD2eec52a1-9016-46dd-8b4c-8dab1d0aeece4
310434gabapentin 800 MG Oral TabletPSNb74a427c-9cc1-4b15-9ed2-cc891741fe673
310434gabapentin 800 MG Oral TabletSCDb74a427c-9cc1-4b15-9ed2-cc891741fe673
310434gabapentin 800 MG Oral TabletPSN026a7219-78ba-48c7-e063-6394a90ad7362
310434gabapentin 800 MG Oral TabletPSN07871ab8-254b-e3c2-e063-6294a90a29ab2
310434gabapentin 800 MG Oral TabletPSN87b9171b-7d00-40fa-87ff-a717740efe8a2
310434gabapentin 800 MG Oral TabletSCD026a7219-78ba-48c7-e063-6394a90ad7362
310434gabapentin 800 MG Oral TabletSCD07871ab8-254b-e3c2-e063-6294a90a29ab2
310434gabapentin 800 MG Oral TabletSCD87b9171b-7d00-40fa-87ff-a717740efe8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-347-0569367034705500 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-347-05) 2021-11-010000-00-00NoNoCurrent