Gabapentin

Product NDC
71610-737
11-digit product format
716100737
Labeler code
71610
Product ID
71610-737_9f352e62-f8a6-4b97-9d27-a147a3439f71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6CW7F3G59XGABAPENTIN60142-96-3GABAPENTIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-737-307161007373030 TABLET in 1 BOTTLE (71610-737-30) 30 tablet2023-09-22NoNoHistorical
71610-737-457161007374545 TABLET in 1 BOTTLE (71610-737-45) 45 tablet2023-09-22NoNoHistorical
71610-737-537161007375360 TABLET in 1 BOTTLE (71610-737-53) 60 tablet2023-09-22NoNoHistorical
71610-737-607161007376090 TABLET in 1 BOTTLE (71610-737-60) 90 tablet2023-09-22NoNoHistorical
71610-737-7071610073770120 TABLET in 1 BOTTLE (71610-737-70) 120 tablet2023-09-22NoNoHistorical
71610-737-7371610073773135 TABLET in 1 BOTTLE (71610-737-73) 135 tablet2023-09-22NoNoHistorical
71610-737-8071610073780180 TABLET in 1 BOTTLE (71610-737-80) 180 tablet2023-09-22NoNoHistorical
71610-737-9271610073792270 TABLET in 1 BOTTLE (71610-737-92) 270 tablet2023-09-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinAphena Pharma Solutions - Tennessee, LLC2023-09-22HUMAN PRESCRIPTION DRUG LABEL1