FDA.reportPublic FDA data

GABAPENTIN

Product NDC
76282-706
11-digit product format
762820706
Labeler code
76282
Product ID
76282-706_96999ce4-193e-4817-939c-900ab87fc88f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
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
GABAPENTIN600 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
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
76282-706-05GABAPENTIN500 in 1 BOTTLETABLET5003
76282-706-90GABAPENTIN90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-706-05EA - Each76282-70611f86ecc-365e-4c24-beba-0585fa3ebe0612021-12-08
76282-706-90EA - Each76282-706cb9c7983-dcde-4abd-ad41-02934a9937c812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-706GABAPENTIN TABLET [EXELAN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20211125_a88edb00-2189-4c8d-9dd7-9fe1571775cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310434gabapentin 800 MG Oral TabletPSNa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310433gabapentin 600 MG Oral TabletSCDa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310434gabapentin 800 MG Oral TabletSCDa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310433gabapentin 600 MG Oral TabletPSN7f579665-afb7-4227-98c1-2eafee6505042
310433gabapentin 600 MG Oral TabletSCD7f579665-afb7-4227-98c1-2eafee6505042
310433gabapentin 600 MG Oral TabletPSN2658e3d6-653c-8eb8-e063-6394a90a479a1
310433gabapentin 600 MG Oral TabletSCD2658e3d6-653c-8eb8-e063-6394a90a479a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-706-0576282070605500 TABLET in 1 BOTTLE (76282-706-05) 500 tablet2021-10-010000-00-00NoNoCurrent
76282-706-907628207069090 TABLET in 1 BOTTLE (76282-706-90) 90 tablet2021-10-010000-00-00NoNoCurrent