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
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-634
Product ID 76420-634_31e2603c-b629-1f0d-e063-6294a90a3646
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2017-03-16

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 76420634
Hyphenated Format 76420-634

Supplemental Identifiers

RxCUI
596926 596930 596934 616402
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 ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-00)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-01)
  • 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-20)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-90)
source: ndc

Packages (6)

76420-634-00 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-00) 76420-634-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-01) 76420-634-20 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-20) 76420-634-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-30) 76420-634-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-60) 76420-634-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-90)

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": "31e2603c-b629-1f0d-e063-6294a90a3646", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["f61bd9f3-cd3d-4c76-a110-0f1dcba610af"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-00)", "package_ndc": "76420-634-00", "marketing_start_date": "20250403"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-01)", "package_ndc": "76420-634-01", "marketing_start_date": "20231017"}, {"sample": false, "description": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-20)", "package_ndc": "76420-634-20", "marketing_start_date": "20250403"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-30)", "package_ndc": "76420-634-30", "marketing_start_date": "20231017"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-60)", "package_ndc": "76420-634-60", "marketing_start_date": "20231017"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-90)", "package_ndc": "76420-634-90", "marketing_start_date": "20231017"}], "brand_name": "Duloxetine", "product_id": "76420-634_31e2603c-b629-1f0d-e063-6294a90a3646", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "76420-634", "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": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20170316", "listing_expiration_date": "20261231"}