FDA.reportPublic FDA data

GABAPENTIN

Product NDC
43353-872
11-digit product format
433530872
Labeler code
43353
Product ID
43353-872_17454231-0b63-4a89-92cb-1c6737ff4f5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202764
Marketing category
ANDA
Marketing start
2012-11-02
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
2022-12-31
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-872-302023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-452023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-532023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-602023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-702023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-732023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-802023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
43353-872-922023-01-30C16284748780-1f386c649-cdc8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-872-30GABAPENTIN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
43353-872-45GABAPENTIN45 in 1 BOTTLE, PLASTICTABLET, FILM COATED454
43353-872-53GABAPENTIN60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
43353-872-60GABAPENTIN90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
43353-872-70GABAPENTIN120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1204
43353-872-73GABAPENTIN135 in 1 BOTTLE, PLASTICTABLET, FILM COATED1354
43353-872-80GABAPENTIN180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804
43353-872-92GABAPENTIN270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2704

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-872-30EA - Each43353-872fa2bd6e9-1e36-49e2-aa98-528477dd853812020-07-13
43353-872-45EA - Each43353-872cb62eaa6-93e2-4f45-9e11-3169ed62913a12014-08-01
43353-872-53EA - Each43353-872e7e24189-e0c3-4f3d-a0d0-19c6bd30de7d12020-07-13
43353-872-60EA - Each43353-87226ce8963-ac26-4517-807f-786f2a63628c12014-08-01
43353-872-70EA - Each43353-872f920f96e-3ba0-4f5b-9c53-70f7ca133cf212021-04-08
43353-872-73EA - Each43353-8726989695e-d848-45de-a7ea-1ecdad485b0912020-01-03
43353-872-80EA - Each43353-872a9200026-ace7-40cb-8823-53d9f2baefb612014-08-01
43353-872-92EA - Each43353-872bb9a26ed-4654-4f2b-8433-240dc03dde8b12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GabapentinACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GabapentinACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CrospovidoneINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Hydroxypropyl CelluloseINACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Hypromellose 2910 (3 mpa.s)INACTIVE INGREDIENT0VUT3PMY82GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MannitolINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TalcINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-872GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 8 package rows20210316_95b96f56-ca06-4715-bcc0-6dd4399e7a6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN95b96f56-ca06-4715-bcc0-6dd4399e7a6c4
310433gabapentin 600 MG Oral TabletSCD95b96f56-ca06-4715-bcc0-6dd4399e7a6c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-872-304335308723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-30) 2020-05-050000-00-00NoNoCurrent
43353-872-454335308724545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-45) 2013-11-130000-00-00NoNoCurrent
43353-872-534335308725360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-53) 2020-05-050000-00-00NoNoCurrent
43353-872-604335308726090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-60) 2013-11-120000-00-00NoNoCurrent
43353-872-7043353087270120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-70) 2021-01-040000-00-00NoNoCurrent
43353-872-7343353087273135 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-73) 2014-08-070000-00-00NoNoCurrent
43353-872-8043353087280180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-80) 2013-11-120000-00-00NoNoCurrent
43353-872-9243353087292270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-92) 2013-11-130000-00-00NoNoCurrent