duloxetine

Generic: duloxetine

Labeler: qingdao baheal pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler qingdao baheal pharmaceutical co., ltd.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Qingdao BAHEAL Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 70247-013
Product ID 70247-013_435c56f7-5995-3906-e063-6394a90af073
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210599
Listing Expiration 2026-12-31
Marketing Start 2018-05-05

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 70247013
Hyphenated Format 70247-013

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0370247013034 0370247014031 0370247014062 0370247012068 0370247014505 0370247013096 0370247013102
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 ANDA210599 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-03)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-09)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-10)
source: ndc

Packages (3)

70247-013-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-03) 70247-013-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-09) 70247-013-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-10)

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": "435c56f7-5995-3906-e063-6394a90af073", "openfda": {"upc": ["0370247013034", "0370247014031", "0370247014062", "0370247012068", "0370247014505", "0370247013096", "0370247013102"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["e428429e-e1ea-40e1-870f-134533dc3aa1"], "manufacturer_name": ["Qingdao BAHEAL Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-03)", "package_ndc": "70247-013-03", "marketing_start_date": "20180508"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-09)", "package_ndc": "70247-013-09", "marketing_start_date": "20180508"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-10)", "package_ndc": "70247-013-10", "marketing_start_date": "20180508"}], "brand_name": "duloxetine", "product_id": "70247-013_435c56f7-5995-3906-e063-6394a90af073", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "70247-013", "generic_name": "Duloxetine", "labeler_name": "Qingdao BAHEAL Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA210599", "marketing_category": "ANDA", "marketing_start_date": "20180505", "listing_expiration_date": "20261231"}