Home SPL Set DailyMed Duloxetine Delayed-release Capsules Duloxetine Delayed-release Capsules SPL v7 SPL SPL Set ID f36b414e-ace4-4f04-a80f-75bb25db430d Route ORAL Published Effective Date 2020-08-26 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Duloxetine (20 mg) Inactive Ingredients 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 Fd&c Red No. 40 Identifiers & Packaging Pill Appearance Imprint: 243;60;mg Shape: capsule Color: green Color: white Color: blue Size: 14 mm Size: 16 mm Size: 19 mm Score: 1 Marketing Status ANDA Active Since 2014-05-27 Description Manufactured by: Cadila Healthcare Ltd. India Medication Information Description Manufactured by: Cadila Healthcare Ltd. India Section 42231-1 Manufactured by: Cadila Healthcare Ltd. India 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 Structured Label Content Section 42231-1 (42231-1) Manufactured by: Cadila Healthcare Ltd. 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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"42231-1": "Manufactured by: Cadila Healthcare Ltd. India", "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"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:59.026466 · Updated: 2026-03-14T22:18:18.443233
