FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0032
11-digit product format
804250032
Labeler code
80425
Product ID
80425-0032_2a988314-623b-2d61-e063-6294a90a3e84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA075350
Marketing category
ANDA
Marketing start
2022-04-03
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
80425-0032-1Gabapentin30 in 1 BOTTLECAPSULE307
80425-0032-2Gabapentin60 in 1 BOTTLECAPSULE607
80425-0032-3Gabapentin90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0032-1EA - Each80425-0032b80b16ca-d581-434b-befd-d0f4a4ea1cc512023-06-06
80425-0032-2EA - Each80425-00325c897bba-3a6b-4511-9c21-a5a34a599fdb12023-06-06
80425-0032-3EA - Each80425-0032333abd39-9683-4ce3-a38d-c97fe86f290112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0032GABAPENTIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_afc80b8b-da39-6fb9-e053-2a95a90a2d8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNafc80b8b-da39-6fb9-e053-2a95a90a2d8e7
310431gabapentin 300 MG Oral CapsuleSCDafc80b8b-da39-6fb9-e053-2a95a90a2d8e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0032-18042500320130 CAPSULE in 1 BOTTLE (80425-0032-1) 30 capsule2022-04-030000-00-00NoNoCurrent
80425-0032-28042500320260 CAPSULE in 1 BOTTLE (80425-0032-2) 60 capsule2022-04-030000-00-00NoNoCurrent
80425-0032-38042500320390 CAPSULE in 1 BOTTLE (80425-0032-3) 90 capsule2022-04-030000-00-00NoNoCurrent