Gabapentin

Product NDC
82804-217
11-digit product format
828040217
Labeler code
82804
Product ID
82804-217_3c8dca11-78ab-45c1-8bb2-89a41ea5dfa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075477
Marketing category
ANDA
Marketing start
2021-11-01
Substance
GABAPENTIN
Active strength
300 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
82804-217-308280402173030 CAPSULE in 1 BOTTLE, PLASTIC (82804-217-30) 30 capsule2025-04-30NoNoHistorical
82804-217-608280402176060 CAPSULE in 1 BOTTLE, PLASTIC (82804-217-60) 60 capsule2025-04-30NoNoHistorical
82804-217-908280402179090 CAPSULE in 1 BOTTLE, PLASTIC (82804-217-90) 90 capsule2025-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GabapentinProficient Rx LP2025-05-01HUMAN PRESCRIPTION DRUG LABEL1