FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0031
11-digit product format
804250031
Labeler code
80425
Product ID
80425-0031_2a988314-623a-2d61-e063-6294a90a3e84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
ADVANCED RX OF TENNESSEE, LLC
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

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
80425-0031-1Gabapentin30 in 1 BOTTLECAPSULE305
80425-0031-2Gabapentin60 in 1 BOTTLECAPSULE605
80425-0031-3Gabapentin90 in 1 BOTTLECAPSULE905
80425-0031-4Gabapentin120 in 1 BOTTLECAPSULE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0031GABAPENTIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 4 package rows20250101_af73fbd8-9731-e6bf-e053-2995a90af65d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNaf73fbd8-9731-e6bf-e053-2995a90af65d5
310431gabapentin 300 MG Oral CapsuleSCDaf73fbd8-9731-e6bf-e053-2995a90af65d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0031-18042500310130 CAPSULE in 1 BOTTLE (80425-0031-1) 30 capsule2018-05-140000-00-00NoNoCurrent
80425-0031-28042500310260 CAPSULE in 1 BOTTLE (80425-0031-2) 60 capsule2018-05-140000-00-00NoNoCurrent
80425-0031-38042500310390 CAPSULE in 1 BOTTLE (80425-0031-3) 90 capsule2018-05-140000-00-00NoNoCurrent
80425-0031-480425003104120 CAPSULE in 1 BOTTLE (80425-0031-4) 120 capsule2023-03-30NoNoCurrent