FDA.reportPublic FDA data

GABAPENTIN

Product NDC
63187-392
11-digit product format
631870392
Labeler code
63187
Product ID
63187-392_01f464f2-61fd-4f72-b718-337159695d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090705
Marketing category
ANDA
Marketing start
2016-06-29
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-392-00GABAPENTIN100 in 1 BOTTLECAPSULE1004
63187-392-03GABAPENTIN03 in 1 BOTTLECAPSULE034
63187-392-30GABAPENTIN30 in 1 BOTTLECAPSULE304
63187-392-60GABAPENTIN60 in 1 BOTTLECAPSULE604
63187-392-72GABAPENTIN120 in 1 BOTTLECAPSULE1204
63187-392-90GABAPENTIN90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-392-00EA - Each63187-3924a7ec11f-1d28-4c13-8c84-466b770922b312017-07-07
63187-392-03EA - Each63187-392849f8666-ff02-403a-8d88-ecef9d9aece812017-06-15
63187-392-30EA - Each63187-392b72aeeee-3add-4e5a-a501-b23a9a7854d612017-04-05
63187-392-60EA - Each63187-3928d0dcb23-ee50-4346-96d2-6227247975ab12017-06-15
63187-392-90EA - Each63187-392ffdc7a5a-42fa-4cac-a9bb-564979fbaaf312016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-392GABAPENTIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20191121_4bae5032-f634-4d1e-b672-8a7e2bd6a5fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN4bae5032-f634-4d1e-b672-8a7e2bd6a5fa4
310430gabapentin 100 MG Oral CapsuleSCD4bae5032-f634-4d1e-b672-8a7e2bd6a5fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-392-0063187039200100 CAPSULE in 1 BOTTLE (63187-392-00) 100 capsule2016-09-010000-00-00NoNoCurrent
63187-392-03631870392033 CAPSULE in 1 BOTTLE (63187-392-03) 3 capsule2017-05-010000-00-00NoNoCurrent
63187-392-306318703923030 CAPSULE in 1 BOTTLE (63187-392-30) 30 capsule2016-09-010000-00-00NoNoCurrent
63187-392-606318703926060 CAPSULE in 1 BOTTLE (63187-392-60) 60 capsule2016-09-010000-00-00NoNoCurrent
63187-392-7263187039272120 CAPSULE in 1 BOTTLE (63187-392-72) 120 capsule2016-09-010000-00-00NoNoCurrent
63187-392-906318703929090 CAPSULE in 1 BOTTLE (63187-392-90) 90 capsule2016-09-010000-00-00NoNoCurrent