duloxetine hydrochloride

Generic: duloxetine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine hydrochloride
Generic Name duloxetine
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-278
Product ID 46708-278_5d679070-7ef4-48c0-a86b-59ed0a606fef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202949
Listing Expiration 2026-12-31
Marketing Start 2014-06-09

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 46708278
Hyphenated Format 46708-278

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0346708278304 0346708279301
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 (source: ndc)
Application Number ANDA202949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91)
source: ndc

Packages (4)

46708-278-10 100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10) 46708-278-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30) 46708-278-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60) 46708-278-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91)

Ingredients (1)

duloxetine hydrochloride (20 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": "5d679070-7ef4-48c0-a86b-59ed0a606fef", "openfda": {"upc": ["0346708278304", "0346708279301"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["05a744a5-64ef-42d7-a19c-568be5a272d4"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10)", "package_ndc": "46708-278-10", "marketing_start_date": "20140609"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30)", "package_ndc": "46708-278-30", "marketing_start_date": "20140609"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60)", "package_ndc": "46708-278-60", "marketing_start_date": "20140609"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91)", "package_ndc": "46708-278-91", "marketing_start_date": "20140609"}], "brand_name": "DULOXETINE HYDROCHLORIDE", "product_id": "46708-278_5d679070-7ef4-48c0-a86b-59ed0a606fef", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "46708-278", "generic_name": "Duloxetine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DULOXETINE HYDROCHLORIDE", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA202949", "marketing_category": "ANDA", "marketing_start_date": "20140609", "listing_expiration_date": "20261231"}