FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0150
11-digit product format
804250150
Labeler code
80425
Product ID
80425-0150_2a99bd40-3c4e-3207-e063-6294a90a4faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA075360
Marketing category
ANDA
Marketing start
2020-09-07
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
80425-0150-2Gabapentin60 in 1 BOTTLECAPSULE608
80425-0150-3Gabapentin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0150-2EA - Each80425-015017c53876-8f99-4025-bc91-cd7cf6fd20bb12023-06-06
80425-0150-3EA - Each80425-0150af5735fc-2e45-4ba0-97bb-5a5ddb83c99612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0150GABAPENTIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 2 package rows20250101_c859e666-d510-426b-e053-2995a90a9a3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNc859e666-d510-426b-e053-2995a90a9a3c8
310430gabapentin 100 MG Oral CapsuleSCDc859e666-d510-426b-e053-2995a90a9a3c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0150-28042501500260 CAPSULE in 1 BOTTLE (80425-0150-2) 60 capsule2020-09-070000-00-00NoNoCurrent
80425-0150-38042501500390 CAPSULE in 1 BOTTLE (80425-0150-3) 90 capsule2020-09-070000-00-00NoNoCurrent