Gabapentin

Product NDC
21695-344
11-digit product format
216950344
Labeler code
21695
Product ID
21695-344_6f3e6391-e711-42bd-9d95-ce15d7a44ed5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA075360
Marketing category
ANDA
Marketing start
2008-11-07
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-344-602019-09-24C16284748780-1934fe258-4ccb-48b1-e053-8cdaa90a720a237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4
21695-344-902019-09-24C16284748780-1934fe258-4ccb-48b1-e053-8cdaa90a720a237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-344-60Gabapentin60 in 1 BOTTLECAPSULE601
21695-344-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-344-60EA - Each21695-344fb2616d2-3492-41f1-9e63-2e40c5dbfbb712012-07-24
21695-344-90EA - Each21695-344b8affa31-fe8a-4c55-b5e3-ff39677de01f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-344GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100305_237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310431gabapentin 300 MG Oral CapsulePSN237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310432gabapentin 400 MG Oral CapsulePSN237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310430gabapentin 100 MG Oral CapsuleSCD237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310431gabapentin 300 MG Oral CapsuleSCD237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310432gabapentin 400 MG Oral CapsuleSCD237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-344-602169503446060 in 1 BOTTLEHistorical
21695-344-902169503449090 in 1 BOTTLEHistorical