Gabapentin

Product NDC
63187-149
11-digit product format
631870149
Labeler code
63187
Product ID
63187-149_6988fc48-a2e8-4be5-861d-13c3be7b0826
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
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-149-30EA - Each63187-14936638a70-58d0-4296-a1fc-a16419d060c312016-09-02
63187-149-90EA - Each63187-149db67d3a5-4f45-4582-9277-21174728195a12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [PROFICIENT RX LP]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [PROFICIENT RX LP]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [PROFICIENT RX LP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [PROFICIENT RX LP]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-149GABAPENTIN TABLET [PROFICIENT RX LP]6Legacy NDC20221020_aacc7c2b-efdc-49b6-869f-107b48cc60a5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-149-306318701493030 TABLET in 1 BOTTLE (63187-149-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-149-606318701496060 TABLET in 1 BOTTLE (63187-149-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-149-7263187014972120 TABLET in 1 BOTTLE (63187-149-72) 120 tablet2019-01-010000-00-00NoNoCurrent
63187-149-906318701499090 TABLET in 1 BOTTLE (63187-149-90) 90 tablet2019-01-010000-00-00NoNoCurrent