FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2765
11-digit product format
713352765
Labeler code
71335
Product ID
71335-2765_5b6860be-3342-47b5-b38e-11c3e903b5cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2765-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED301
71335-2765-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED601
71335-2765-3Gabapentin90 in 1 BOTTLETABLET, FILM COATED901
71335-2765-4Gabapentin180 in 1 BOTTLETABLET, FILM COATED1801
71335-2765-5Gabapentin120 in 1 BOTTLETABLET, FILM COATED1201
71335-2765-6Gabapentin100 in 1 BOTTLETABLET, FILM COATED1001
71335-2765-7Gabapentin84 in 1 BOTTLETABLET, FILM COATED841
71335-2765-8Gabapentin112 in 1 BOTTLETABLET, FILM COATED1121
71335-2765-9Gabapentin135 in 1 BOTTLETABLET, FILM COATED1351

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2765-1EA - Each71335-2765d787f65c-f355-43d6-826d-b755f47fd54a12026-01-08
71335-2765-2EA - Each71335-2765a93c0db4-8d8d-46fd-8bf7-967b0d44e32212026-01-08
71335-2765-3EA - Each71335-2765c27c67af-8ecf-4643-8e24-562e9fec773612026-01-08
71335-2765-5EA - Each71335-276558672ba0-ebd6-469b-b569-11ca7f7c54c212026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNbe9a572d-e98a-41c1-83c5-859d9176dd1c1
310434gabapentin 800 MG Oral TabletSCDbe9a572d-e98a-41c1-83c5-859d9176dd1c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2765-17133527650130 TABLET, FILM COATED in 1 BOTTLE (71335-2765-1) 2025-10-03NoNoHistorical
71335-2765-27133527650260 TABLET, FILM COATED in 1 BOTTLE (71335-2765-2) 2025-10-03NoNoHistorical
71335-2765-37133527650390 TABLET, FILM COATED in 1 BOTTLE (71335-2765-3) 2025-10-03NoNoHistorical
71335-2765-471335276504180 TABLET, FILM COATED in 1 BOTTLE (71335-2765-4) 2025-10-03NoNoHistorical
71335-2765-571335276505120 TABLET, FILM COATED in 1 BOTTLE (71335-2765-5) 2025-10-03NoNoHistorical
71335-2765-671335276506100 TABLET, FILM COATED in 1 BOTTLE (71335-2765-6) 2025-10-03NoNoHistorical
71335-2765-77133527650784 TABLET, FILM COATED in 1 BOTTLE (71335-2765-7) 2025-10-03NoNoHistorical
71335-2765-871335276508112 TABLET, FILM COATED in 1 BOTTLE (71335-2765-8) 2025-10-03NoNoHistorical
71335-2765-971335276509135 TABLET, FILM COATED in 1 BOTTLE (71335-2765-9) 2025-10-03NoNoHistorical