FDA.reportPublic FDA data

Gabapentin

Product NDC
82804-015
11-digit product format
828040015
Labeler code
82804
Product ID
82804-015_9c96b488-19bd-431e-af9a-b313ffd9eaae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-04-11
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
82804-015-30Gabapentin30 in 1 BOTTLETABLET301
82804-015-60Gabapentin60 in 1 BOTTLETABLET601
82804-015-90Gabapentin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-015-30EA - Each82804-015beaa987c-ea4c-4045-b569-70e7fd1dee2d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-015GABAPENTIN TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20231005_9c96b488-19bd-431e-af9a-b313ffd9eaae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN9c96b488-19bd-431e-af9a-b313ffd9eaae1
310433gabapentin 600 MG Oral TabletSCD9c96b488-19bd-431e-af9a-b313ffd9eaae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-015-308280400153030 TABLET in 1 BOTTLE (82804-015-30) 30 tablet2023-10-03NoNoCurrent
82804-015-608280400156060 TABLET in 1 BOTTLE (82804-015-60) 60 tablet2023-10-03NoNoCurrent
82804-015-908280400159090 TABLET in 1 BOTTLE (82804-015-90) 90 tablet2023-10-03NoNoCurrent