FDA.reportPublic FDA data

Gabapentin

Product NDC
60505-0113
11-digit product format
605050113
Labeler code
60505
Product ID
60505-0113_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
2022-05-31
Substance
GABAPENTIN
Active strength
300 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
60505-0113-0EA - Each60505-01135147df3f-5ce5-461a-9ec7-05dc98854ff412012-07-24
60505-0113-1EA - Each60505-0113c6614e60-3da0-42c0-b3f8-2f26d987936a12012-07-24
60505-0113-7EA - Each60505-01132d86dcde-3ca4-44d9-b023-d25df88aa35212012-07-24
60505-0113-8EA - Each60505-01136ff6194e-bcb9-420e-9691-ced4d82db1cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
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
310431gabapentin 300 MG Oral CapsulePSN39ce8bbc-7df9-45f4-ab5a-b319d2b25c8820
310431gabapentin 300 MG Oral CapsuleSCD39ce8bbc-7df9-45f4-ab5a-b319d2b25c8820
310431gabapentin 300 MG Oral CapsulePSNb61dcc9b-0a0e-4841-b4f5-2e04e433c60911
310431gabapentin 300 MG Oral CapsuleSCDb61dcc9b-0a0e-4841-b4f5-2e04e433c60911
310431gabapentin 300 MG Oral CapsulePSN2550a291-51f6-473f-89cd-193bbe97662a2
310432gabapentin 400 MG Oral CapsulePSN2550a291-51f6-473f-89cd-193bbe97662a2
310431gabapentin 300 MG Oral CapsuleSCD2550a291-51f6-473f-89cd-193bbe97662a2
310432gabapentin 400 MG Oral CapsuleSCD2550a291-51f6-473f-89cd-193bbe97662a2
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
60505-0113-160505011301100 CAPSULE in 1 BOTTLE (60505-0113-1) 100 capsule2005-04-062021-12-21NoNoCurrent
60505-0113-8605050113081000 CAPSULE in 1 BOTTLE (60505-0113-8) 1000 capsule2005-04-062022-05-31NoNoCurrent