FDA.reportPublic FDA data

Duloxetine hydrochloride

Product NDC
13668-110
11-digit product format
136680110
Labeler code
13668
Product ID
13668-110_eb315d7b-0f80-4192-abdc-9d158e788dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetin hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090774
Marketing category
ANDA
Marketing start
2013-12-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-110-05EA - Each13668-110676d7bfb-6d80-4f79-9621-1ed357b0eec812014-01-04
13668-110-30EA - Each13668-110e47d7468-78d8-4b12-a7da-86b0310c058c12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-110DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]16Legacy NDC20241004_b82656d8-e22e-42e5-9b97-887e6d09a68c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2b6118ba-344e-4b41-89fa-c16d6e50927f2
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2b6118ba-344e-4b41-89fa-c16d6e50927f2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2b6118ba-344e-4b41-89fa-c16d6e50927f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-110-0113668011001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-110-01) 2013-12-110000-00-00NoNoCurrent
13668-110-0513668011005500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-110-05) 2013-12-110000-00-00NoNoCurrent
13668-110-301366801103030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-110-30) 2013-12-110000-00-00NoNoCurrent
13668-110-7413668011074100 CAPSULE, DELAYED RELEASE in 1 CARTON (13668-110-74) 2013-12-110000-00-00NoNoCurrent