FDA.reportPublic FDA data

Gabapentin

Product NDC
45865-356
11-digit product format
458650356
Labeler code
45865
Product ID
45865-356_9700d830-6f75-d9c6-e053-2a95a90ab4f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-356-302025-01-30C16284748780-12cef2736-7417-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
45865-356-492025-01-30C16284748780-12cef2736-7417-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
45865-356-512025-01-30C16284748780-12cef2736-7417-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
45865-356-602025-01-30C16284748780-12cef2736-7417-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
45865-356-902025-01-30C16284748780-12cef2736-7417-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use gabapentin safely and effectively. See full prescribing information for gabapentin . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-356-30Gabapentin30 in 1 BOTTLETABLET306
45865-356-49Gabapentin100 in 1 BOTTLETABLET1006
45865-356-51Gabapentin120 in 1 BOTTLETABLET1206
45865-356-60Gabapentin60 in 1 BOTTLETABLET606
45865-356-90Gabapentin90 in 1 BOTTLETABLET906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-356GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]6Legacy NDC, 5 package rows20191111_1d382246-eec8-69cc-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN1d382246-eec8-69cc-e054-00144ff8d46c6
310433gabapentin 600 MG Oral TabletSCD1d382246-eec8-69cc-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-356-304586503563030 TABLET in 1 BOTTLE (45865-356-30) 30 tablet2015-08-140000-00-00NoNoCurrent
45865-356-4945865035649100 TABLET in 1 BOTTLE (45865-356-49) 100 tablet2015-08-140000-00-00NoNoCurrent
45865-356-5145865035651120 TABLET in 1 BOTTLE (45865-356-51) 120 tablet2015-08-140000-00-00NoNoCurrent
45865-356-604586503566060 TABLET in 1 BOTTLE (45865-356-60) 60 tablet2015-08-140000-00-00NoNoCurrent
45865-356-904586503569090 TABLET in 1 BOTTLE (45865-356-90) 90 tablet2015-08-140000-00-00NoNoCurrent