Gabapentin

Product NDC
63187-006
11-digit product format
631870006
Labeler code
63187
Product ID
63187-006_be2722d9-bb72-41c4-b2ec-5c58a5410ec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx
Application
ANDA075694
Marketing category
ANDA
Marketing start
2004-02-14
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
2020-12-31
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
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
63187-006-90EA - Each63187-006cc707c96-d8d7-42c3-bad0-59e832bbe0a112016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET, FILM COATED [PROFICIENT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-006GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]2Legacy NDC20191126_69c094f4-1ffe-4d36-8143-34f4bed175c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-006-906318700069090 TABLET, FILM COATED in 1 BOTTLE (63187-006-90) 2014-05-010000-00-00NoNoCurrent