Gabapentin

Product NDC
64725-0126
11-digit product format
647250126
Labeler code
64725
Product ID
64725-0126_7a56733c-238a-4b87-b713-39220882bd53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
TYA 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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0126-12019-11-27C16284748780-19855e2a2-4131-60a7-e053-dbdaa90a05bdGabapentin Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0126-1Gabapentin100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [TYA PHARMACEUTICALS]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0126GABAPENTIN TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140902_e85790f2-8fab-4a2c-92fb-aeae6d6855a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNe85790f2-8fab-4a2c-92fb-aeae6d6855a22
310433gabapentin 600 MG Oral TabletSCDe85790f2-8fab-4a2c-92fb-aeae6d6855a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0126-164725012601100 in 1 BOTTLEHistorical