duloxetine delayed-release

Generic: duloxetine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine delayed-release
Generic Name duloxetine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-743
Product ID 71610-743_3724601a-53f8-5bd3-e063-6394a90a98a6
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 71610743
Hyphenated Format 71610-743

Supplemental Identifiers

RxCUI
596934
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
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-30)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-53)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-60)
  • 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-74)
  • 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-80)
source: ndc

Packages (5)

71610-743-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-30) 71610-743-53 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-53) 71610-743-60 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-60) 71610-743-74 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-74) 71610-743-80 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-80)

Ingredients (1)

duloxetine hydrochloride (60 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": "3724601a-53f8-5bd3-e063-6394a90a98a6", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["3bae1317-4cc8-4d86-b1b6-15edee733a6d"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-30)", "package_ndc": "71610-743-30", "marketing_start_date": "20231016"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-53)", "package_ndc": "71610-743-53", "marketing_start_date": "20231016"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-60)", "package_ndc": "71610-743-60", "marketing_start_date": "20231016"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-74)", "package_ndc": "71610-743-74", "marketing_start_date": "20250605"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-80)", "package_ndc": "71610-743-80", "marketing_start_date": "20240320"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "71610-743_3724601a-53f8-5bd3-e063-6394a90a98a6", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "71610-743", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "Delayed-Release", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20261231"}