GABAPENTIN

Product NDC
82804-193
11-digit product format
828040193
Labeler code
82804
Product ID
82804-193_87922d62-3d7e-496c-b6ea-6946b75df97f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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
82804-193-30GABAPENTIN30 in 1 BOTTLETABLET302
82804-193-90GABAPENTIN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-193-30EA - Each82804-193fc5130ee-a09c-46e6-a44b-ffe9c2b1967212025-06-13
82804-193-90EA - Each82804-1935cc1af21-4491-45af-b7ce-934218eaaf4b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-193GABAPENTIN TABLET [PROFICIENT RX LP]2Current NDC, 2 package rows20250419_7fcce531-bf7c-43b6-bea9-8f0602842c53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7fcce531-bf7c-43b6-bea9-8f0602842c532
310433gabapentin 600 MG Oral TabletSCD7fcce531-bf7c-43b6-bea9-8f0602842c532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-193-308280401933030 TABLET in 1 BOTTLE (82804-193-30) 30 tablet2025-04-16NoNoHistorical
82804-193-908280401939090 TABLET in 1 BOTTLE (82804-193-90) 90 tablet2025-02-07NoNoHistorical