duloxetine hydrochloride

Generic: duloxetine hydrochloride

Labeler: yaopharma co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine hydrochloride
Generic Name duloxetine hydrochloride
Labeler yaopharma co., ltd.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Yaopharma Co., Ltd.

Identifiers & Regulatory

Product NDC 50771-202
Product ID 50771-202_4502c810-4eb5-29c4-e063-6394a90aefe4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207219
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 50771202
Hyphenated Format 50771-202

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0350771203019 0350771202012 0350771201015
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 hydrochloride (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA207219 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-01)
  • 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-02)
source: ndc

Packages (2)

50771-202-01 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-01) 50771-202-02 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-02)

Ingredients (1)

duloxetine hydrochloride (30 mg/1)

Linked Drug Pages (1)

DULOXETINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4502c810-4eb5-29c4-e063-6394a90aefe4", "openfda": {"upc": ["0350771203019", "0350771202012", "0350771201015"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["90224073-178d-7ec5-e053-2995a90a20fc"], "manufacturer_name": ["Yaopharma Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-01)", "package_ndc": "50771-202-01", "marketing_start_date": "20240101"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-02)", "package_ndc": "50771-202-02", "marketing_start_date": "20240101"}], "brand_name": "DULOXETINE HYDROCHLORIDE", "product_id": "50771-202_4502c810-4eb5-29c4-e063-6394a90aefe4", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "50771-202", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Yaopharma Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DULOXETINE HYDROCHLORIDE", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA207219", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}