duloxetine

Generic: duloxetine

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

duloxetine hydrochloride 20 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-097
Product ID 27241-097_ae1a8c02-c1fc-474a-9411-cebecd99e339
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 27241097
Hyphenated Format 27241-097

Supplemental Identifiers

RxCUI
596926 596930 596934 616402
UPC
0327241164309 0327241099038 0327241097065 0327241098031
UNII
9044SC542W

Packaging Origin

Original Packager
true

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
  • 20 mg/1
source: ndc
Packaging
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-05)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-06)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-90)
source: ndc

Packages (4)

27241-097-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-05) 27241-097-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-06) 27241-097-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-10) 27241-097-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-90)

Ingredients (1)

duloxetine hydrochloride (20 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": "ae1a8c02-c1fc-474a-9411-cebecd99e339", "openfda": {"upc": ["0327241164309", "0327241099038", "0327241097065", "0327241098031"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["2dde979d-b6f8-41d1-96fb-325c75ea3a74"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-05)", "package_ndc": "27241-097-05", "marketing_start_date": "20211018"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-06)", "package_ndc": "27241-097-06", "marketing_start_date": "20170316"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-10)", "package_ndc": "27241-097-10", "marketing_start_date": "20170316"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-90)", "package_ndc": "27241-097-90", "marketing_start_date": "20211018"}], "brand_name": "Duloxetine", "product_id": "27241-097_ae1a8c02-c1fc-474a-9411-cebecd99e339", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "27241-097", "generic_name": "Duloxetine", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20170316", "listing_expiration_date": "20261231"}