FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71335-1454
11-digit product format
713351454
Labeler code
71335
Product ID
71335-1454_eebc392f-b112-477a-af02-59ae539281ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090705
Marketing category
ANDA
Marketing start
2017-12-05
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1454-12024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-22024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-32024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-42024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-52024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-62024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-72024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-82024-12-23C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-12024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-22024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-32024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-42024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-52024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-62024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-72024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-82024-01-30C16284748780-11030e365-38ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1454-1GABAPENTIN90 in 1 BOTTLECAPSULE9010
71335-1454-2GABAPENTIN28 in 1 BOTTLECAPSULE2810
71335-1454-3GABAPENTIN58 in 1 BOTTLECAPSULE5810
71335-1454-4GABAPENTIN30 in 1 BOTTLECAPSULE3010
71335-1454-5GABAPENTIN60 in 1 BOTTLECAPSULE6010
71335-1454-6GABAPENTIN120 in 1 BOTTLECAPSULE12010
71335-1454-7GABAPENTIN180 in 1 BOTTLECAPSULE18010
71335-1454-8GABAPENTIN40 in 1 BOTTLECAPSULE4010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1454GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 8 package rows20241225_1fd95278-842f-4bf9-abd5-4d9aa858d36d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN1fd95278-842f-4bf9-abd5-4d9aa858d36d10
310431gabapentin 300 MG Oral CapsuleSCD1fd95278-842f-4bf9-abd5-4d9aa858d36d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1454-17133514540190 CAPSULE in 1 BOTTLE (71335-1454-1) 90 capsule2019-12-300000-00-00NoNoCurrent
71335-1454-27133514540228 CAPSULE in 1 BOTTLE (71335-1454-2) 28 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-37133514540358 CAPSULE in 1 BOTTLE (71335-1454-3) 58 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-47133514540430 CAPSULE in 1 BOTTLE (71335-1454-4) 30 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-57133514540560 CAPSULE in 1 BOTTLE (71335-1454-5) 60 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-671335145406120 CAPSULE in 1 BOTTLE (71335-1454-6) 120 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-771335145407180 CAPSULE in 1 BOTTLE (71335-1454-7) 180 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-87133514540840 CAPSULE in 1 BOTTLE (71335-1454-8) 40 capsule2024-12-100000-00-00NoNoCurrent