FDA.reportPublic FDA data

Gabapentin

Product NDC
43353-709
11-digit product format
433530709
Labeler code
43353
Product ID
43353-709_63578037-37d7-4aff-8c75-da3338940c06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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
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
43353-709-302020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-532020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-602020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-702020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-802020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-922020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-942020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP
43353-709-982020-01-31C16284748780-19d75b9d0-9394-f424-e053-dadaa90a57ceGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-709-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE301
43353-709-53Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
43353-709-60Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE901
43353-709-70Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1201
43353-709-80Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE1801
43353-709-92Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE2701
43353-709-94Gabapentin360 in 1 BOTTLE, PLASTICCAPSULE3601
43353-709-98Gabapentin540 in 1 BOTTLE, PLASTICCAPSULE5401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-709-30EA - Each43353-70977f63466-ed65-44b0-bcfc-242d816353d112013-02-13
43353-709-53EA - Each43353-709f6ce294a-3e87-46d1-9e9f-1597677ac14812013-02-13
43353-709-60EA - Each43353-70957a32301-178d-4273-8a94-53f0a217bb9f12013-02-13
43353-709-70EA - Each43353-709f49c2fe6-8a8c-4157-99fc-50776a1054b212013-02-13
43353-709-80EA - Each43353-709aed37c96-9ad3-4132-a296-3422648f25b812013-02-13
43353-709-92EA - Each43353-70918ad1081-ec68-4bef-b005-7bca3130d3d912013-02-13
43353-709-94EA - Each43353-709110ee3cd-d91e-4815-a382-7a740250e72512013-02-13
43353-709-98EA - Each43353-709c390aab6-3038-42ca-be21-7442e4ad711712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-709GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1Legacy NDC, 8 package rows20121129_493e0603-8148-457b-a743-342f51c4c57a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN493e0603-8148-457b-a743-342f51c4c57a1
310431gabapentin 300 MG Oral CapsulePSN493e0603-8148-457b-a743-342f51c4c57a1
310432gabapentin 400 MG Oral CapsulePSN493e0603-8148-457b-a743-342f51c4c57a1
310430gabapentin 100 MG Oral CapsuleSCD493e0603-8148-457b-a743-342f51c4c57a1
310431gabapentin 300 MG Oral CapsuleSCD493e0603-8148-457b-a743-342f51c4c57a1
310432gabapentin 400 MG Oral CapsuleSCD493e0603-8148-457b-a743-342f51c4c57a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-709-304335307093030 in 1 BOTTLE, PLASTICHistorical
43353-709-534335307095360 in 1 BOTTLE, PLASTICHistorical
43353-709-604335307096090 in 1 BOTTLE, PLASTICHistorical
43353-709-7043353070970120 in 1 BOTTLE, PLASTICHistorical
43353-709-8043353070980180 in 1 BOTTLE, PLASTICHistorical
43353-709-9243353070992270 in 1 BOTTLE, PLASTICHistorical
43353-709-9443353070994360 in 1 BOTTLE, PLASTICHistorical
43353-709-9843353070998540 in 1 BOTTLE, PLASTICHistorical