FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0128
11-digit product format
804250128
Labeler code
80425
Product ID
80425-0128_2a99b834-0c97-6f97-e063-6394a90a8407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
80425-0128-2Gabapentin60 in 1 BOTTLECAPSULE607
80425-0128-3Gabapentin90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0128-2EA - Each80425-01283db7f5e7-95e7-4141-96a1-eed0d59be0d112023-06-06
80425-0128-3EA - Each80425-012876cc130e-6f1b-4e32-9b77-20b973741a7012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0128GABAPENTIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_bc08e35d-ef5d-1dcd-e053-2a95a90ab5de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNbc08e35d-ef5d-1dcd-e053-2a95a90ab5de7
310430gabapentin 100 MG Oral CapsuleSCDbc08e35d-ef5d-1dcd-e053-2a95a90ab5de7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0128-28042501280260 CAPSULE in 1 BOTTLE (80425-0128-2) 60 capsule2023-02-20NoNoHistorical
80425-0128-38042501280390 CAPSULE in 1 BOTTLE (80425-0128-3) 90 capsule2023-02-20NoNoHistorical