Duloxetine hydrochloride
These highlights do not include all the information needed to use duloxetine delayed-release capsules, USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules, USP. DULOXETINE delayed-release capsules USP, for oral use. Initial U.S. Approval: 2004
Approved
Approval ID
2b6118ba-344e-4b41-89fa-c16d6e50927f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2014
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Duloxetin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-1100
Application NumberANDA090774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Duloxetin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2014
FDA Product Classification
INGREDIENTS (12)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DULOXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT