flector

Generic: diclofenac epolamine

Labeler: ibsa pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name flector
Generic Name diclofenac epolamine
Labeler ibsa pharma inc.
Dosage Form SYSTEM
Routes
TOPICAL
Active Ingredients

diclofenac epolamine .013 g/1

Manufacturer
IBSA Pharma Inc.

Identifiers & Regulatory

Product NDC 71858-0405
Product ID 71858-0405_41a95307-60af-f937-e063-6394a90aa82a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021234
Listing Expiration 2026-12-31
Marketing Start 2020-11-01

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] decreased prostaglandin production [pe] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 718580405
Hyphenated Format 71858-0405

Supplemental Identifiers

RxCUI
855626 855628
UNII
X5F8EKL9ZG

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 flector (source: ndc)
Generic Name diclofenac epolamine (source: ndc)
Application Number NDA021234 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .013 g/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1)
  • 6 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4)
  • 3 POUCH in 1 CARTON (71858-0405-6) / 5 SYSTEM in 1 POUCH (71858-0405-4)
source: ndc

Packages (3)

71858-0405-2 1 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1) 71858-0405-5 6 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4) 71858-0405-6 3 POUCH in 1 CARTON (71858-0405-6) / 5 SYSTEM in 1 POUCH (71858-0405-4)

Ingredients (1)

diclofenac epolamine (.013 g/1)

Linked Drug Pages (1)

FLECTOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "41a95307-60af-f937-e063-6394a90aa82a", "openfda": {"unii": ["X5F8EKL9ZG"], "rxcui": ["855626", "855628"], "spl_set_id": ["1f19a016-c4fc-43c5-9990-e5f2e2776a82"], "manufacturer_name": ["IBSA Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 POUCH in 1 CARTON (71858-0405-2)  / 2 SYSTEM in 1 POUCH (71858-0405-1)", "package_ndc": "71858-0405-2", "marketing_start_date": "20201101"}, {"sample": false, "description": "6 POUCH in 1 CARTON (71858-0405-5)  / 5 SYSTEM in 1 POUCH (71858-0405-4)", "package_ndc": "71858-0405-5", "marketing_start_date": "20201101"}, {"sample": false, "description": "3 POUCH in 1 CARTON (71858-0405-6)  / 5 SYSTEM in 1 POUCH (71858-0405-4)", "package_ndc": "71858-0405-6", "marketing_start_date": "20260201"}], "brand_name": "FLECTOR", "product_id": "71858-0405_41a95307-60af-f937-e063-6394a90aa82a", "dosage_form": "SYSTEM", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71858-0405", "generic_name": "diclofenac epolamine", "labeler_name": "IBSA Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLECTOR", "active_ingredients": [{"name": "DICLOFENAC EPOLAMINE", "strength": ".013 g/1"}], "application_number": "NDA021234", "marketing_category": "NDA", "marketing_start_date": "20201101", "listing_expiration_date": "20261231"}