duloxetine delayed-release

Generic: duloxetine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6889
Product ID 50090-6889_2bcd10f1-d5c6-4886-ac10-39e7a658448d
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 500906889
Hyphenated Format 50090-6889

Supplemental Identifiers

RxCUI
596926
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
  • 20 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-0)
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-1)
source: ndc

Packages (2)

50090-6889-0 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-0) 50090-6889-1 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-1)

Ingredients (1)

duloxetine hydrochloride (20 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": "2bcd10f1-d5c6-4886-ac10-39e7a658448d", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926"], "spl_set_id": ["be33f3cb-6fd1-4377-816e-84bd49370e9e"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-0)", "package_ndc": "50090-6889-0", "marketing_start_date": "20231206"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-1)", "package_ndc": "50090-6889-1", "marketing_start_date": "20231206"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "50090-6889_2bcd10f1-d5c6-4886-ac10-39e7a658448d", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "50090-6889", "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": "20 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20261231"}