FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2048
11-digit product format
713352048
Labeler code
71335
Product ID
71335-2048_c8480861-4d12-4b83-abe8-3a6f182de239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206402
Marketing category
ANDA
Marketing start
2015-11-01
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

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
71335-2048-1Gabapentin90 in 1 BOTTLETABLET90110
71335-2048-2Gabapentin58 in 1 BOTTLETABLET58110
71335-2048-3Gabapentin100 in 1 BOTTLETABLET100110
71335-2048-4Gabapentin120 in 1 BOTTLETABLET120110
71335-2048-5Gabapentin60 in 1 BOTTLETABLET60110
71335-2048-6Gabapentin30 in 1 BOTTLETABLET30110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2048-1EA - Each71335-204834ccf2f0-e618-4363-8d68-50fca28d8b1812022-04-06
71335-2048-4EA - Each71335-2048ef3e6a7d-5592-48c7-a230-db5576b50de812022-04-06
71335-2048-5EA - Each71335-2048ccc49ce8-9c7a-470f-bf67-1ebac5b5f46e12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2048GABAPENTIN TABLET [BRYANT RANCH PREPACK]110Current NDC, Legacy NDC, 6 package rows20250226_df9c7c84-a8d9-4da8-babe-c55c9420d4e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNdf9c7c84-a8d9-4da8-babe-c55c9420d4e6110
310433gabapentin 600 MG Oral TabletSCDdf9c7c84-a8d9-4da8-babe-c55c9420d4e6110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2048-17133520480190 TABLET in 1 BOTTLE (71335-2048-1) 90 tablet2022-03-150000-00-00NoNoCurrent
71335-2048-27133520480258 TABLET in 1 BOTTLE (71335-2048-2) 58 tablet2025-01-300000-00-00NoNoCurrent
71335-2048-371335204803100 TABLET in 1 BOTTLE (71335-2048-3) 100 tablet2022-12-270000-00-00NoNoCurrent
71335-2048-471335204804120 TABLET in 1 BOTTLE (71335-2048-4) 120 tablet2022-03-220000-00-00NoNoCurrent
71335-2048-57133520480560 TABLET in 1 BOTTLE (71335-2048-5) 60 tablet2022-02-210000-00-00NoNoCurrent
71335-2048-67133520480630 TABLET in 1 BOTTLE (71335-2048-6) 30 tablet2023-06-210000-00-00NoNoCurrent