duloxetine delayed-release (50090-3205)

Drug Facts

Product Profile

Brand Name duloxetine delayed-release

Generic Name duloxetine hydrochloride

Labeler a-s medication solutions

Dosage Form CAPSULE, DELAYED RELEASE PELLETS

Routes

ORAL

Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3205

Product ID 50090-3205_bb6e2af6-0020-470b-addb-df7bb4724ac7

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 500903205

Hyphenated Format 50090-3205

Supplemental Identifiers

RxCUI

596930

UNII

9044SC542W

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

30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-0)
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-1)

source: ndc

Packages (2)

50090-3205-0 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-0) 50090-3205-1 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-1)

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": "bb6e2af6-0020-470b-addb-df7bb4724ac7", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["3eb24fa9-921b-4bdb-9e0a-c82cb600df0f"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-0)", "package_ndc": "50090-3205-0", "marketing_start_date": "20171205"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-1)", "package_ndc": "50090-3205-1", "marketing_start_date": "20171024"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "50090-3205_bb6e2af6-0020-470b-addb-df7bb4724ac7", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "50090-3205", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "A-S Medication Solutions", "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"}