FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-0254
11-digit product format
713350254
Labeler code
71335
Product ID
71335-0254_ff2cb055-20dd-4dbc-bace-8d13e9ae4da2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
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

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 Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0254-12024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-22024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-32024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-42024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-52024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-62024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-72024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-82024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-92024-10-23C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-12024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-22024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-32024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-42024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-52024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-62024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-72024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-82024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
71335-0254-92024-01-30C16284748780-11030e365-4be6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0254-1Gabapentin30 in 1 BOTTLETABLET306
71335-0254-2Gabapentin60 in 1 BOTTLETABLET606
71335-0254-3Gabapentin90 in 1 BOTTLETABLET906
71335-0254-4Gabapentin180 in 1 BOTTLETABLET1806
71335-0254-5Gabapentin120 in 1 BOTTLETABLET1206
71335-0254-6Gabapentin100 in 1 BOTTLETABLET1006
71335-0254-7Gabapentin84 in 1 BOTTLETABLET846
71335-0254-8Gabapentin112 in 1 BOTTLETABLET1126
71335-0254-9Gabapentin135 in 1 BOTTLETABLET1356

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0254-2EA - Each71335-0254a86750f8-4e6d-4276-9e35-97516e5395ff12018-07-03
71335-0254-3EA - Each71335-0254e70de841-b8ca-41b7-afe0-5a497ab5414f12018-04-19
71335-0254-4EA - Each71335-0254c61e788c-ba61-4b67-823d-1acb8656db8712018-06-11
71335-0254-5EA - Each71335-025405fa59b6-dc04-46c3-b746-17b37d96dfa912018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0254GABAPENTIN TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20241025_2278ce1b-1c19-4ad2-89c6-4530f7b78ea7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN2278ce1b-1c19-4ad2-89c6-4530f7b78ea76
310434gabapentin 800 MG Oral TabletSCD2278ce1b-1c19-4ad2-89c6-4530f7b78ea76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0254-17133502540130 TABLET in 1 BOTTLE (71335-0254-1) 30 tablet2018-07-190000-00-00NoNoCurrent
71335-0254-27133502540260 TABLET in 1 BOTTLE (71335-0254-2) 60 tablet2018-05-040000-00-00NoNoCurrent
71335-0254-37133502540390 TABLET in 1 BOTTLE (71335-0254-3) 90 tablet2018-03-150000-00-00NoNoCurrent
71335-0254-471335025404180 TABLET in 1 BOTTLE (71335-0254-4) 180 tablet2018-05-110000-00-00NoNoCurrent
71335-0254-571335025405120 TABLET in 1 BOTTLE (71335-0254-5) 120 tablet2018-04-170000-00-00NoNoCurrent
71335-0254-671335025406100 TABLET in 1 BOTTLE (71335-0254-6) 100 tablet2024-10-080000-00-00NoNoCurrent
71335-0254-77133502540784 TABLET in 1 BOTTLE (71335-0254-7) 84 tablet2018-04-030000-00-00NoNoCurrent
71335-0254-871335025408112 TABLET in 1 BOTTLE (71335-0254-8) 112 tablet2024-10-080000-00-00NoNoCurrent
71335-0254-971335025409135 TABLET in 1 BOTTLE (71335-0254-9) 135 tablet2024-10-080000-00-00NoNoCurrent