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Duloxetine

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

c34f6115-f447-450f-8c83-58f3c51a76c9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 1, 2021

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Duloxetine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63187-612
Application NumberANDA090778
Product Classification
M
Marketing Category
C73584
G
Generic Name
Duloxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2021
FDA Product Classification

INGREDIENTS (18)

FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DULOXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT

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Duloxetine - FDA Drug Approval Details