FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1026
11-digit product format
713351026
Labeler code
71335
Product ID
71335-1026_db7c39b3-ffdf-452c-b42e-f4be1b60c638
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
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

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
71335-1026-1Gabapentin90 in 1 BOTTLETABLET, FILM COATED90104
71335-1026-2Gabapentin58 in 1 BOTTLETABLET, FILM COATED58104
71335-1026-3Gabapentin100 in 1 BOTTLETABLET, FILM COATED100104
71335-1026-4Gabapentin120 in 1 BOTTLETABLET, FILM COATED120104
71335-1026-5Gabapentin60 in 1 BOTTLETABLET, FILM COATED60104
71335-1026-6Gabapentin30 in 1 BOTTLETABLET, FILM COATED30104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1026-1EA - Each71335-10260577fbdb-80c1-4f7a-8aff-0ed64bb3518f12019-04-11
71335-1026-3EA - Each71335-10268578312b-3faa-4fa3-8e94-4b52b98a2f4712024-08-12
71335-1026-4EA - Each71335-1026ae723d20-1b62-4aa6-8b48-7d0251debeae12024-08-12
71335-1026-5EA - Each71335-10264ce63716-1307-4dac-b34a-d0ef1969015012019-04-11
71335-1026-6EA - Each71335-1026a0435201-841a-4c93-bf07-bf4fe69af9f212019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1026GABAPENTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 6 package rows20240709_6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb104
310433gabapentin 600 MG Oral TabletSCD6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1026-17133510260190 TABLET, FILM COATED in 1 BOTTLE (71335-1026-1) 2018-12-130000-00-00NoNoCurrent
71335-1026-27133510260258 TABLET, FILM COATED in 1 BOTTLE (71335-1026-2) 2024-04-020000-00-00NoNoCurrent
71335-1026-371335102603100 TABLET, FILM COATED in 1 BOTTLE (71335-1026-3) 2019-09-110000-00-00NoNoCurrent
71335-1026-471335102604120 TABLET, FILM COATED in 1 BOTTLE (71335-1026-4) 2019-03-140000-00-00NoNoCurrent
71335-1026-57133510260560 TABLET, FILM COATED in 1 BOTTLE (71335-1026-5) 2019-01-110000-00-00NoNoCurrent
71335-1026-67133510260630 TABLET, FILM COATED in 1 BOTTLE (71335-1026-6) 2019-01-300000-00-00NoNoCurrent