duloxetine

Generic: duloxetine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

duloxetine hydrochloride 30 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1054
Product ID 70518-1054_4af0f952-aef1-1a5e-e063-6394a90a41b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2027-12-31
Marketing Start 2018-03-09

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 705181054
Hyphenated Format 70518-1054

Supplemental Identifiers

RxCUI
596930
UNII
9044SC542W

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
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-0)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-6)
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-7)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-9)
source: ndc

Packages (4)

70518-1054-0 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-0) 70518-1054-6 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-6) 70518-1054-7 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-7) 70518-1054-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-9)

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": "4af0f952-aef1-1a5e-e063-6394a90a41b2", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["b149641a-03e6-4fee-91f3-7ba8e01196bd"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-0)", "package_ndc": "70518-1054-0", "marketing_start_date": "20180309"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-6)", "package_ndc": "70518-1054-6", "marketing_start_date": "20210609"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1054-7)", "package_ndc": "70518-1054-7", "marketing_start_date": "20210625"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1054-9)", "package_ndc": "70518-1054-9", "marketing_start_date": "20211202"}], "brand_name": "Duloxetine", "product_id": "70518-1054_4af0f952-aef1-1a5e-e063-6394a90a41b2", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "70518-1054", "generic_name": "Duloxetine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20180309", "listing_expiration_date": "20271231"}