duloxetine

Generic: duloxetine

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler nucare pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3766
Product ID 68071-3766_2b61d5b5-490b-5494-e063-6294a90a3fa1
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 680713766
Hyphenated Format 68071-3766

Supplemental Identifiers

RxCUI
596930
UPC
0368071376692
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
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3766-9)
source: ndc

Packages (1)

68071-3766-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3766-9)

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": "2b61d5b5-490b-5494-e063-6294a90a3fa1", "openfda": {"upc": ["0368071376692"], "unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["2b61c261-d7f2-4f9d-e063-6294a90acc24"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3766-9)", "package_ndc": "68071-3766-9", "marketing_start_date": "20250110"}], "brand_name": "Duloxetine", "product_id": "68071-3766_2b61d5b5-490b-5494-e063-6294a90a3fa1", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68071-3766", "generic_name": "Duloxetine", "labeler_name": "NuCare Pharmaceuticals, 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"}