FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0079
11-digit product format
804250079
Labeler code
80425
Product ID
80425-0079_2a9914d0-6556-747c-e063-6294a90a946c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
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
80425-0079-1Gabapentin30 in 1 BOTTLECAPSULE308
80425-0079-2Gabapentin60 in 1 BOTTLECAPSULE608
80425-0079-3Gabapentin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0079-1EA - Each80425-0079156e411b-e1f2-4460-9cc5-9b0f2f9cf3c512023-06-06
80425-0079-2EA - Each80425-0079a05e3189-5a5e-4124-9eb3-b10aaf17fddc12023-06-06
80425-0079-3EA - Each80425-0079a5cc297e-b491-4928-a738-424fd4df2c7a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0079GABAPENTIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_b062f12c-a745-76d4-e053-2a95a90a3a1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNb062f12c-a745-76d4-e053-2a95a90a3a1a8
310431gabapentin 300 MG Oral CapsuleSCDb062f12c-a745-76d4-e053-2a95a90a3a1a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0079-18042500790130 CAPSULE in 1 BOTTLE (80425-0079-1) 30 capsule2015-12-300000-00-00NoNoCurrent
80425-0079-28042500790260 CAPSULE in 1 BOTTLE (80425-0079-2) 60 capsule2015-12-300000-00-00NoNoCurrent
80425-0079-38042500790390 CAPSULE in 1 BOTTLE (80425-0079-3) 90 capsule2015-12-300000-00-00NoNoCurrent