duloxetine

Generic: duloxetine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler asclemed usa, inc.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-236
Product ID 76420-236_e347f58a-9f2f-7e64-e053-2a95a90a528b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090776
Listing Expiration 2026-12-31
Marketing Start 2013-12-17

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 76420236
Hyphenated Format 76420-236

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 (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number ANDA090776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-30)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-60)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-90)
source: ndc

Packages (3)

76420-236-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-30) 76420-236-60 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-60) 76420-236-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-90)

Ingredients (1)

duloxetine hydrochloride (30 mg/1)

Linked Drug Pages (1)

Duloxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e347f58a-9f2f-7e64-e053-2a95a90a528b", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["7c755ca3-0855-4b54-80a8-01b85f8e644a"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-30)", "package_ndc": "76420-236-30", "marketing_start_date": "20220707"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-60)", "package_ndc": "76420-236-60", "marketing_start_date": "20220707"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-90)", "package_ndc": "76420-236-90", "marketing_start_date": "20220707"}], "brand_name": "Duloxetine", "product_id": "76420-236_e347f58a-9f2f-7e64-e053-2a95a90a528b", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "76420-236", "generic_name": "Duloxetine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA090776", "marketing_category": "ANDA", "marketing_start_date": "20131217", "listing_expiration_date": "20261231"}