FDA.reportPublic FDA data

Gabapentin

Product NDC
63187-010
11-digit product format
631870010
Labeler code
63187
Product ID
63187-010_34b3a9d3-242c-449b-ba6a-ebb2ecf4f37b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-010-30Gabapentin30 in 1 BOTTLETABLET306
63187-010-60Gabapentin60 in 1 BOTTLETABLET606
63187-010-90Gabapentin90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-010-30EA - Each63187-010e2e07f4f-fe85-42f9-a985-ac0f5fbdc6d812017-03-06
63187-010-60EA - Each63187-01033294c26-db45-4be1-9b6a-f394fd2df83012016-09-02
63187-010-90EA - Each63187-010df91ad7c-2797-4991-a242-77a67ddde35a12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [PROFICIENT RX LP]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [PROFICIENT RX LP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [PROFICIENT RX LP]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [PROFICIENT RX LP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [PROFICIENT RX LP]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [PROFICIENT RX LP]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [PROFICIENT RX LP]3
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-010GABAPENTIN TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20191025_c78f528f-9192-4037-bfb9-ff5718ed26c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNc78f528f-9192-4037-bfb9-ff5718ed26c56
310434gabapentin 800 MG Oral TabletPSNc78f528f-9192-4037-bfb9-ff5718ed26c56
310433gabapentin 600 MG Oral TabletSCDc78f528f-9192-4037-bfb9-ff5718ed26c56
310434gabapentin 800 MG Oral TabletSCDc78f528f-9192-4037-bfb9-ff5718ed26c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-010-306318700103030 TABLET in 1 BOTTLE (63187-010-30) 30 tablet2016-12-010000-00-00NoNoCurrent
63187-010-606318700106060 TABLET in 1 BOTTLE (63187-010-60) 60 tablet2014-04-010000-00-00NoNoCurrent
63187-010-906318700109090 TABLET in 1 BOTTLE (63187-010-90) 90 tablet2014-04-010000-00-00NoNoCurrent