FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0036
11-digit product format
804250036
Labeler code
80425
Product ID
80425-0036_2a985a04-15d4-b8b6-e063-6394a90a4231
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
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
80425-0036-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED306
80425-0036-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0036-1EA - Each80425-00365c562dbf-5ee0-48eb-9c06-e35d28108d9f12023-04-07
80425-0036-2EA - Each80425-0036e96f3ee2-d4af-4e10-b89f-e07615e3bcd412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0036GABAPENTIN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_afa28969-91c8-83fd-e053-2a95a90a656b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNafa28969-91c8-83fd-e053-2a95a90a656b6
310434gabapentin 800 MG Oral TabletSCDafa28969-91c8-83fd-e053-2a95a90a656b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0036-18042500360130 TABLET, FILM COATED in 1 BOTTLE (80425-0036-1) 2011-10-060000-00-00NoNoCurrent
80425-0036-28042500360260 TABLET, FILM COATED in 1 BOTTLE (80425-0036-2) 2011-10-060000-00-00NoNoCurrent