Gabapentin

Product NDC
42254-054
11-digit product format
422540054
Labeler code
42254
Product ID
42254-054_f8c7c414-fcd2-47dd-8226-8d0c35d3e9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077662
Marketing category
ANDA
Marketing start
2011-02-09
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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-054-00Gabapentin100 in 1 BOTTLE, PLASTICTABLET1004
42254-054-30Gabapentin30 in 1 BOTTLE, PLASTICTABLET304
42254-054-60Gabapentin60 in 1 BOTTLE, PLASTICTABLET604
42254-054-72Gabapentin120 in 1 BOTTLE, PLASTICTABLET1204
42254-054-90Gabapentin90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-054-00EA - Each42254-05420fa260c-18bb-4dc4-8643-fc7812affdb112013-02-13
42254-054-30EA - Each42254-0547595e0c4-2656-4ec2-bf78-3fec801f9fca12012-07-24
42254-054-60EA - Each42254-0546c547a8c-eb3c-47ec-828c-d902b691966f12012-07-24
42254-054-72EA - Each42254-054c37876dd-6199-4bb9-a386-e90b3ad9154e12012-07-24
42254-054-90EA - Each42254-05447903cf0-fa7e-4ba7-8ee6-8489a002bcc112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-054GABAPENTIN TABLET [REBEL DISTRIBUTORS CORP]4Legacy NDC, 5 package rows20130221_5dbdcf46-c0d9-4249-81fa-75bef5a69d84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310434gabapentin 800 MG Oral TabletPSN5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310433gabapentin 600 MG Oral TabletSCD5dbdcf46-c0d9-4249-81fa-75bef5a69d844
310434gabapentin 800 MG Oral TabletSCD5dbdcf46-c0d9-4249-81fa-75bef5a69d844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-054-0042254005400100 in 1 BOTTLE, PLASTICHistorical
42254-054-304225400543030 in 1 BOTTLE, PLASTICHistorical
42254-054-604225400546060 in 1 BOTTLE, PLASTICHistorical
42254-054-7242254005472120 in 1 BOTTLE, PLASTICHistorical
42254-054-904225400549090 in 1 BOTTLE, PLASTICHistorical