Gabapentin

Product NDC
63187-231
11-digit product format
631870231
Labeler code
63187
Product ID
63187-231_b5b3b2b0-9279-4b16-b1ae-b9388fcdf736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202764
Marketing category
ANDA
Marketing start
2012-10-29
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-231-60EA - Each63187-2316bd550e3-e17b-49ce-a9dd-e1b3254ace6e12016-09-02
63187-231-90EA - Each63187-23127c5da3d-e85e-44dd-9c1e-fac0e721f21e12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-231GABAPENTIN TABLET [PROFICIENT RX LP]3Legacy NDC20210121_71d84c83-b58b-44b6-a6fc-851f4f3b6c29.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-231-0063187023100100 TABLET in 1 BOTTLE (63187-231-00) 100 tablet2018-12-010000-00-00NoNoCurrent
63187-231-306318702313030 TABLET in 1 BOTTLE (63187-231-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-231-606318702316060 TABLET in 1 BOTTLE (63187-231-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-231-7263187023172120 TABLET in 1 BOTTLE (63187-231-72) 120 tablet2018-12-010000-00-00NoNoCurrent
63187-231-7863187023178180 TABLET in 1 BOTTLE (63187-231-78) 180 tablet2018-12-010000-00-00NoNoCurrent
63187-231-906318702319090 TABLET in 1 BOTTLE (63187-231-90) 90 tablet2018-12-010000-00-00NoNoCurrent