cymbalta

Generic: duloxetine hydrochloride

Labeler: eli lilly and company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cymbalta
Generic Name duloxetine hydrochloride
Labeler eli lilly and company
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Eli Lilly and Company

Identifiers & Regulatory

Product NDC 0002-3270
Product ID 0002-3270_aa5061b1-f237-425a-9d05-575c333dfd37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021427
Marketing Start 2010-01-15
Marketing End 2026-10-02

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 00023270
Hyphenated Format 0002-3270

Supplemental Identifiers

RxCUI
596926 596928 596930 596932 596934 615186
UPC
0300023270306 0300023240309 0300023235602
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 cymbalta (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number NDA021427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied CYMBALTA (duloxetine delayed-release capsules) is available in the following strengths, colors, imprints, and presentations: a equivalent to duloxetine base Features Strengths 20 mg a 30 mg a 60 mg a Body color Opaque green Opaque white Opaque green Cap color Opaque green Opaque blue Opaque blue Cap imprint Lilly 3235 Lilly 3240 Lilly 3270 Body imprint 20mg 30mg 60mg Capsule number PU3235 PU3240 PU3270 Presentations and NDC Codes Bottles of 30 NA 0002-3240-30 0002-3270-30 Bottles of 60 0002-3235-60 NA NA Bottles of 90 NA 0002-3240-90 NA 16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
  • 16.1 How Supplied CYMBALTA (duloxetine delayed-release capsules) is available in the following strengths, colors, imprints, and presentations: a equivalent to duloxetine base Features Strengths 20 mg a 30 mg a 60 mg a Body color Opaque green Opaque white Opaque green Cap color Opaque green Opaque blue Opaque blue Cap imprint Lilly 3235 Lilly 3240 Lilly 3270 Body imprint 20mg 30mg 60mg Capsule number PU3235 PU3240 PU3270 Presentations and NDC Codes Bottles of 30 NA 0002-3240-30 0002-3270-30 Bottles of 60 0002-3235-60 NA NA Bottles of 90 NA 0002-3240-90 NA
  • PACKAGE LABEL- Cymbalta 20 mg, bottle of 60 NDC 0002-3235-60 60 capsules PU3235 Cymbalta ® duloxetine delayed release capsules 20 mg Each capsule contains 22.4 mg of duloxetine hydrochloride equivalent to 20 mg duloxetine. Rx only Lilly PACKAGE LABEL- Cymbalta 20 mg, bottle of 60
  • PACKAGE LABEL- Cymbalta 30 mg, bottle of 30 NDC 0002-3240-30 30 capsules PU3240 Cymbalta ® duloxetine delayed release capsules 30 mg Each capsule contains 33.7 mg of duloxetine hydrochloride equivalent to 30 mg duloxetine. Rx only Lilly PACKAGE LABEL- Cymbalta 30 mg, bottle of 30
  • PACKAGE LABEL- Cymbalta 60 mg, bottle of 30 NDC 0002-3270-30 30 capsules PU3270 Cymbalta ® duloxetine delayed release capsules 60 mg Each capsule contains 67.3 mg of duloxetine hydrochloride equivalent to 60 mg duloxetine. Rx only Lilly PACKAGE LABEL- Cymbalta 60 mg, bottle of 30
source: label

Packages (0)

No package records.

Ingredients (1)

duloxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Cymbalta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aa5061b1-f237-425a-9d05-575c333dfd37", "openfda": {"upc": ["0300023270306", "0300023240309", "0300023235602"], "unii": ["9044SC542W"], "rxcui": ["596926", "596928", "596930", "596932", "596934", "615186"], "spl_set_id": ["2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba"], "manufacturer_name": ["Eli Lilly and Company"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Cymbalta", "product_id": "0002-3270_aa5061b1-f237-425a-9d05-575c333dfd37", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "0002-3270", "generic_name": "Duloxetine hydrochloride", "labeler_name": "Eli Lilly and Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cymbalta", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "NDA021427", "marketing_category": "NDA", "marketing_end_date": "20261002", "marketing_start_date": "20100115"}