Gabapentin

Product NDC
21695-055
11-digit product format
216950055
Labeler code
21695
Product ID
21695-055_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
2009-09-24
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
21695-055-00Gabapentin100 in 1 BOTTLECAPSULE1001
21695-055-30Gabapentin30 in 1 BOTTLECAPSULE301
21695-055-60Gabapentin60 in 1 BOTTLECAPSULE601
21695-055-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-055-00EA - Each21695-0556816814e-2d64-4410-a8c7-9f696c768dc712012-07-24
21695-055-30EA - Each21695-0558264ff43-fea1-4952-84d0-098dc567ce1b12012-07-24
21695-055-60EA - Each21695-0550ab2ad2a-c886-4f8f-8573-b8b6d31a59d512012-07-24
21695-055-90EA - Each21695-05503f12230-bc83-4e02-9bfa-a4c5db4be60512012-07-24

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
21695-055GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 4 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
21695-055-0021695005500100 in 1 BOTTLEHistorical
21695-055-302169500553030 in 1 BOTTLEHistorical
21695-055-602169500556060 in 1 BOTTLEHistorical
21695-055-902169500559090 in 1 BOTTLEHistorical