duloxetine delayed-release (51991-747)

Drug Facts

Product Profile

Brand Name duloxetine delayed-release

Generic Name duloxetine hydrochloride

Labeler breckenridge pharmaceutical, inc.

Dosage Form CAPSULE, DELAYED RELEASE PELLETS

Routes

ORAL

Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer

Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-747

Product ID 51991-747_32327581-bdab-41ac-9adc-bf208e1c4e42

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203088

Listing Expiration 2026-12-31

Marketing Start 2014-06-11

Pharmacologic Class

Classes

norepinephrine uptake inhibitors [moa] serotonin uptake inhibitors [moa] serotonin and norepinephrine reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991747

Hyphenated Format 51991-747

Supplemental Identifiers

RxCUI

596926 596930 596934 616402

UNII

9044SC542W

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name duloxetine delayed-release (source: ndc)

Generic Name duloxetine hydrochloride (source: ndc)

Application Number ANDA203088 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/1

source: ndc

Packaging

1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-10)
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-33)
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-90)

source: ndc

Packages (3)

51991-747-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-10) 51991-747-33 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-33) 51991-747-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-90)

Ingredients (1)

duloxetine hydrochloride (30 mg/1)

Linked Drug Pages (1)

Duloxetine Delayed-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "32327581-bdab-41ac-9adc-bf208e1c4e42", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["caef6f50-1571-4ec7-8f8c-42b924d323ee"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-10)", "package_ndc": "51991-747-10", "marketing_start_date": "20140611"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-33)", "package_ndc": "51991-747-33", "marketing_start_date": "20140611"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-90)", "package_ndc": "51991-747-90", "marketing_start_date": "20140611"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "51991-747_32327581-bdab-41ac-9adc-bf208e1c4e42", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "51991-747", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "Delayed-Release", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20261231"}