Gabapentin

Product NDC
71610-667
11-digit product format
716100667
Labeler code
71610
Product ID
71610-667_96c283e4-dad6-4cc6-88cf-7c50285ef6a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
71610-667-307161006673030 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-30) 30 capsule2022-10-10NoNoHistorical
71610-667-537161006675360 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-53) 60 capsule2022-10-10NoNoHistorical
71610-667-607161006676090 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-60) 90 capsule2022-10-10NoNoHistorical
71610-667-8071610066780180 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-80) 180 capsule2022-10-10NoNoHistorical
71610-667-9271610066792270 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-92) 270 capsule2022-10-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinAphena Pharma Solutions - Tennessee, LLC2022-10-18HUMAN PRESCRIPTION DRUG LABEL3