Duloxetine

Product NDC
82804-024
11-digit product format
828040024
Labeler code
82804
Product ID
82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203088
Marketing category
ANDA
Marketing start
2018-05-21
Substance
DULOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9044SC542WDULOXETINE HYDROCHLORIDE136434-34-9DULOXETINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-024-308280400243030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30) 2023-10-16NoNoHistorical
82804-024-608280400246060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60) 2023-10-16NoNoHistorical
82804-024-908280400249090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90) 2023-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Duloxetine Delayed-Release - Proficient Rx LPProficient Rx LP2023-10-01HUMAN PRESCRIPTION DRUG LABEL1