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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6CW7F3G59XGABAPENTIN60142-96-3GABAPENTIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-015-308280400153030 TABLET in 1 BOTTLE (82804-015-30) 30 tablet2023-10-03NoNoHistorical
82804-015-608280400156060 TABLET in 1 BOTTLE (82804-015-60) 60 tablet2023-10-03NoNoHistorical
82804-015-908280400159090 TABLET in 1 BOTTLE (82804-015-90) 90 tablet2023-10-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinProficient Rx LP2023-10-01HUMAN PRESCRIPTION DRUG LABEL1