NDC 55700-079

Duloxetine

Duloxetine Hydrochloride

Duloxetine is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Duloxetine Hydrochloride.

Product ID55700-079_ae72dc41-5548-49ea-90ab-6f7c96f180d3
NDC55700-079
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA090778
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-079-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-079-30)
Marketing Start Date2014-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-079-60 [55700007960]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-02-17
Marketing End Date2019-10-11

NDC 55700-079-90 [55700007990]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-02-17
Marketing End Date2019-10-11

NDC 55700-079-30 [55700007930]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-02-17
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:99d1f641-8cef-4138-ab76-853185a8e481
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596934

    • Pharmacological Class

    • Norepinephrine Uptake Inhibitors [MoA]
    • Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "Duloxetine" or generic name "Duloxetine Hydrochloride"

    NDCBrand NameGeneric Name
    0093-7542DuloxetineDuloxetine
    0093-7543DuloxetineDuloxetine
    0093-7544DuloxetineDuloxetine
    0228-2890DuloxetineDuloxetine
    0228-2891DuloxetineDuloxetine
    0228-2892DuloxetineDuloxetine
    67877-264DuloxetineDuloxetine
    67877-265DuloxetineDuloxetine
    67877-263DuloxetineDuloxetine
    68001-255DuloxetineDuloxetine
    68001-256DuloxetineDuloxetine
    68001-257DuloxetineDuloxetine
    68071-4700DuloxetineDuloxetine
    68084-692DuloxetineDuloxetine
    68084-675DuloxetineDuloxetine
    68084-683DuloxetineDuloxetine
    68151-4727DuloxetineDuloxetine
    68180-294DuloxetineDuloxetine
    68180-297DuloxetineDuloxetine
    68180-295DuloxetineDuloxetine
    68180-296DuloxetineDuloxetine
    68382-385DuloxetineDuloxetine
    68382-386DuloxetineDuloxetine
    68382-387DuloxetineDuloxetine
    68788-6427duloxetineduloxetine
    68788-9262DuloxetineDuloxetine
    68788-9266DuloxetineDuloxetine
    69097-298duloxetineduloxetine
    69097-297duloxetineduloxetine
    69097-299duloxetineduloxetine
    70518-0491DuloxetineDuloxetine
    70518-1066DuloxetineDuloxetine
    70518-0937DuloxetineDuloxetine
    70518-1054DuloxetineDuloxetine
    70518-1139DuloxetineDuloxetine
    70518-0685DuloxetineDuloxetine
    70518-1128DULOXETINEDULOXETINE
    70518-1011DuloxetineDuloxetine
    70518-1244DuloxetineDuloxetine
    70518-1137DuloxetineDuloxetine
    70518-1765DuloxetineDuloxetine
    70710-1537DuloxetineDuloxetine
    70518-1891DuloxetineDuloxetine
    70710-1538DuloxetineDuloxetine
    70771-1344DuloxetineDuloxetine
    70710-1539DuloxetineDuloxetine
    70771-1346DuloxetineDuloxetine
    70771-1345DuloxetineDuloxetine
    71205-005DuloxetineDuloxetine
    71335-0367DuloxetineDuloxetine
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