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Duloxetine - Medication Information

Product NDC Code 65841-801
Drug Name

Duloxetine

Type Generic
Pharm Class Norepinephrine Uptake Inhibitors [MoA],
Serotonin Uptake Inhibitors [MoA],
Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
Active Ingredients
Duloxetine hydrochloride 60 mg/1
Route ORAL
Dosage Form CAPSULE, DELAYED RELEASE
RxCUI drug identifier 596926,
596930,
596934
Application Number ANDA090739
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-801-06 30 capsule, delayed release in 1 bottle (65841-801-06)
65841-801-10 1000 capsule, delayed release in 1 bottle (65841-801-10)
65841-801-16 90 capsule, delayed release in 1 bottle (65841-801-16)
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Spl product data elements

Usually a list of ingredients in a drug product.
Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE ALCOHOL AMMONIA BUTYL ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) HYPROMELLOSES ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE GREEN WHITE CAPSULE 241;20;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10 FD&C RED NO. 40 FD&C YELLOW NO. 6 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE GREEN CAPSULE 242;30;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C RED NO. 40 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE WHITE CAPSULE 243;60;mg

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-799-16 Duloxetine Delayed-release Capsules, 20mg 90 Capsules Rx only NDC 65841-800-16 Duloxetine Delayed-release Capsules, 30mg 90 Capsules Rx only NDC 65841-801-16 Duloxetine Delayed-release Capsules, 60mg 90 Capsules Rx only Duloxetine delayed-release capsules Duloxetine delayed-release capsules Duloxetine delayed-release capsules

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
Manufactured by: Cadila Healthcare Ltd. India

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API