Gabapentin

Product NDC
71205-485
11-digit product format
712050485
Labeler code
71205
Product ID
71205-485_5ebc3c8b-7e36-4c3c-807a-110b2a21c639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
400 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

Additional Listing Data

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
GABAPENTIN400 mg/1

Harmonized Identifiers

FieldValues
Unii6CW7F3G59X
Rxcui310432

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6CW7F3G59XGABAPENTIN60142-96-3GABAPENTIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-485-307120504853030 CAPSULE in 1 BOTTLE (71205-485-30) 30 capsule2020-10-140000-00-00NoNoCurrent
71205-485-607120504856060 CAPSULE in 1 BOTTLE (71205-485-60) 60 capsule2020-10-140000-00-00NoNoCurrent
71205-485-7271205048572120 CAPSULE in 1 BOTTLE (71205-485-72) 120 capsule2020-10-140000-00-00NoNoCurrent
71205-485-907120504859090 CAPSULE in 1 BOTTLE (71205-485-90) 90 capsule2020-10-140000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinProficient Rx LP2022-08-01HUMAN PRESCRIPTION DRUG LABEL2