DULOXETINE

Product NDC
70518-3177
11-digit product format
705183177
Labeler code
70518
Product ID
70518-3177_c893e87d-f9a5-6fe8-e053-2a95a90aae84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206653
Marketing category
ANDA
Marketing start
2021-07-31
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3177-02023-03-20C16284748780-1f386c64a-2d2c-0266-e053-dadaa90a7c1ad3f1bbc6-dfba-4f6b-aa49-c923bffca236
70518-3177-02023-01-30C16284748780-1f386c64a-2d2c-0266-e053-dadaa90a7c1ad3f1bbc6-dfba-4f6b-aa49-c923bffca236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3177-07051831770090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3177-0) 2021-07-310000-00-00NoNoCurrent