FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-1054
11-digit product format
705181054
Labeler code
70518
Product ID
70518-1054_4af0f952-aef1-1a5e-e063-6394a90a41b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2018-03-09
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1054-0Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3022
70518-1054-1Duloxetine90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9022
70518-1054-2Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3022
70518-1054-3Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6022
70518-1054-4Duloxetine30 in 1 BOXCAPSULE, DELAYED RELEASE3022
70518-1054-5Duloxetine1 in 1 POUCHCAPSULE, DELAYED RELEASE122
70518-1054-6Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3022
70518-1054-7Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3022
70518-1054-8Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3022
70518-1054-9Duloxetine90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1054-6EA - Each70518-105405ebbd9e-7004-4e1f-a969-59c20eba151512026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1054DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]19Current NDC, Legacy NDC, 10 package rows20250509_b149641a-03e6-4fee-91f3-7ba8e01196bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb149641a-03e6-4fee-91f3-7ba8e01196bd22
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb149641a-03e6-4fee-91f3-7ba8e01196bd22
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb149641a-03e6-4fee-91f3-7ba8e01196bd22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1054-07051810540030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-0) 2018-03-09NoNoHistorical
70518-1054-17051810540190 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-1) 2019-08-220000-00-00NoNoCurrent
70518-1054-27051810540230 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-2) 2020-02-280000-00-00NoNoCurrent
70518-1054-37051810540360 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-3) 2020-07-290000-00-00NoNoCurrent
70518-1054-47051810540430 POUCH in 1 BOX (70518-1054-4) > 1 CAPSULE, DELAYED RELEASE in 1 POUCH (70518-1054-5) 30 pouch2021-02-010000-00-00NoNoCurrent
70518-1054-5705181054051 in 1 POUCHHistorical
70518-1054-67051810540630 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-6) 2021-06-090000-00-00NoNoCurrent
70518-1054-77051810540730 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-7) 2021-06-250000-00-00NoNoCurrent
70518-1054-87051810540830 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-8) 2021-10-070000-00-00NoNoCurrent
70518-1054-97051810540990 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-9) 2021-12-020000-00-00NoNoCurrent