Gabapentin

Product NDC
60505-0112
11-digit product format
605050112
Labeler code
60505
Product ID
60505-0112_495d183d-f43e-cd94-750f-632891121be7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075360
Marketing category
ANDA
Marketing start
2005-04-06
Marketing end
2022-02-28
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0112-0EA - Each60505-0112c76f91c1-3c7e-4037-9b6b-707cd73809f112012-07-24
60505-0112-1EA - Each60505-0112fb71dad1-307e-4487-bdec-f0ecd26fda4312012-07-24
60505-0112-7EA - Each60505-0112bdd90cd7-59ed-4c62-8cc5-bcb8340a5bf512012-07-24
60505-0112-8EA - Each60505-011290d04ed4-60c3-4e30-8b4b-be5261111a8c12012-07-24

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNfd0d48d6-2cfb-4221-bedc-1b16121f4d052
310430gabapentin 100 MG Oral CapsuleSCDfd0d48d6-2cfb-4221-bedc-1b16121f4d052
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0112-160505011201100 CAPSULE in 1 BOTTLE (60505-0112-1) 100 capsule2005-04-062021-02-28NoNoCurrent
60505-0112-8605050112081000 CAPSULE in 1 BOTTLE (60505-0112-8) 1000 capsule2005-04-062022-02-28NoNoCurrent