Gabapentin

Product NDC
64725-0511
11-digit product format
647250511
Labeler code
64725
Product ID
64725-0511_e1cd96a9-6dfc-455a-9624-ba92e9c85c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA075350
Marketing category
ANDA
Marketing start
2010-01-23
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 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
64725-0511-12019-11-27C16284748780-19855e2a2-4710-60a7-e053-dbdaa90a05bdGABAPENTIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0511-1Gabapentin100 in 1 BOTTLECAPSULE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0511GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140902_c6a27c24-d0f2-4591-b951-b047b59bfff6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNc6a27c24-d0f2-4591-b951-b047b59bfff62
310430gabapentin 100 MG Oral CapsuleSCDc6a27c24-d0f2-4591-b951-b047b59bfff62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0511-164725051101100 in 1 BOTTLEHistorical