FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0204
11-digit product format
804250204
Labeler code
80425
Product ID
80425-0204_2a99e9e8-3d19-ee0b-e063-6294a90ae4ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA207057
Marketing category
ANDA
Marketing start
2022-10-28
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

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
80425-0204-1Gabapentin30 in 1 BOTTLETABLET, COATED309
80425-0204-2Gabapentin60 in 1 BOTTLETABLET, COATED609
80425-0204-3Gabapentin90 in 1 BOTTLETABLET, COATED909
80425-0204-4Gabapentin120 in 1 BOTTLETABLET, COATED1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0204-1EA - Each80425-0204e73c8fa5-e977-4333-9a9e-6d327418ee5412023-04-07
80425-0204-2EA - Each80425-0204399d501c-dd77-4e55-a046-267d4c6b40f412023-04-07
80425-0204-3EA - Each80425-02049917ab2b-d6e3-407d-a6c7-626236dcc83e12023-06-06
80425-0204-4EA - Each80425-020492f9aa86-d807-4c38-b74a-ac18a6def30412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0204GABAPENTIN TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 4 package rows20250101_ec1a01fe-5531-21df-e053-2a95a90a0561.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNec1a01fe-5531-21df-e053-2a95a90a05619
310434gabapentin 800 MG Oral TabletPSNec1a01fe-5531-21df-e053-2a95a90a05619
310433gabapentin 600 MG Oral TabletSCDec1a01fe-5531-21df-e053-2a95a90a05619
310434gabapentin 800 MG Oral TabletSCDec1a01fe-5531-21df-e053-2a95a90a05619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0204-18042502040130 TABLET, COATED in 1 BOTTLE (80425-0204-1) 2023-11-010000-00-00NoNoCurrent
80425-0204-28042502040260 TABLET, COATED in 1 BOTTLE (80425-0204-2) 2023-11-010000-00-00NoNoCurrent
80425-0204-38042502040390 TABLET, COATED in 1 BOTTLE (80425-0204-3) 2023-11-01NoNoCurrent
80425-0204-480425020404120 TABLET, COATED in 1 BOTTLE (80425-0204-4) 2023-11-01NoNoCurrent