FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1007
11-digit product format
713351007
Labeler code
71335
Product ID
71335-1007_b749e1c1-83fc-4693-99e8-1341909d80f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

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
71335-1007-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED307
71335-1007-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED607
71335-1007-3Gabapentin90 in 1 BOTTLETABLET, FILM COATED907
71335-1007-4Gabapentin180 in 1 BOTTLETABLET, FILM COATED1807
71335-1007-5Gabapentin120 in 1 BOTTLETABLET, FILM COATED1207
71335-1007-6Gabapentin100 in 1 BOTTLETABLET, FILM COATED1007
71335-1007-7Gabapentin84 in 1 BOTTLETABLET, FILM COATED847
71335-1007-8Gabapentin112 in 1 BOTTLETABLET, FILM COATED1127
71335-1007-9Gabapentin135 in 1 BOTTLETABLET, FILM COATED1357

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1007GABAPENTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 9 package rows20240410_47f2a06f-4eac-4dca-aa2a-a36dd4daaea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN47f2a06f-4eac-4dca-aa2a-a36dd4daaea07
310434gabapentin 800 MG Oral TabletSCD47f2a06f-4eac-4dca-aa2a-a36dd4daaea07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1007-17133510070130 TABLET, FILM COATED in 1 BOTTLE (71335-1007-1) 2019-08-010000-00-00NoNoCurrent
71335-1007-27133510070260 TABLET, FILM COATED in 1 BOTTLE (71335-1007-2) 2018-11-140000-00-00NoNoCurrent
71335-1007-37133510070390 TABLET, FILM COATED in 1 BOTTLE (71335-1007-3) 2018-11-140000-00-00NoNoCurrent
71335-1007-471335100704180 TABLET, FILM COATED in 1 BOTTLE (71335-1007-4) 2024-04-090000-00-00NoNoCurrent
71335-1007-571335100705120 TABLET, FILM COATED in 1 BOTTLE (71335-1007-5) 2019-01-280000-00-00NoNoCurrent
71335-1007-671335100706100 TABLET, FILM COATED in 1 BOTTLE (71335-1007-6) 2024-04-090000-00-00NoNoCurrent
71335-1007-77133510070784 TABLET, FILM COATED in 1 BOTTLE (71335-1007-7) 2024-04-090000-00-00NoNoCurrent
71335-1007-871335100708112 TABLET, FILM COATED in 1 BOTTLE (71335-1007-8) 2024-04-090000-00-00NoNoCurrent
71335-1007-971335100709135 TABLET, FILM COATED in 1 BOTTLE (71335-1007-9) 2024-04-090000-00-00NoNoCurrent