diclofenac epolamine

Generic: diclofenac epolamine

Labeler: yaral pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

diclofenac epolamine .013 g/1

Manufacturer
YARAL Pharma Inc.

Identifiers & Regulatory

Product NDC 82347-0405
Product ID 82347-0405_41a96431-3fd8-a73e-e063-6294a90a5ec5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021234
Listing Expiration 2026-12-31
Marketing Start 2022-11-18

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 823470405
Hyphenated Format 82347-0405

Supplemental Identifiers

RxCUI
855626
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 diclofenac epolamine (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
  • 6 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4)
  • 3 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4)
source: ndc

Packages (2)

82347-0405-5 6 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4) 82347-0405-6 3 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4)

Ingredients (1)

diclofenac epolamine (.013 g/1)

Linked Drug Pages (1)

Diclofenac Epolamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "41a96431-3fd8-a73e-e063-6294a90a5ec5", "openfda": {"unii": ["X5F8EKL9ZG"], "rxcui": ["855626"], "spl_set_id": ["2d9bfacc-1b0c-4fab-b949-cd0c914089f9"], "manufacturer_name": ["YARAL Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (82347-0405-5)  / 5 SYSTEM in 1 POUCH (82347-0405-4)", "package_ndc": "82347-0405-5", "marketing_start_date": "20221118"}, {"sample": false, "description": "3 POUCH in 1 CARTON (82347-0405-6)  / 5 SYSTEM in 1 POUCH (82347-0405-4)", "package_ndc": "82347-0405-6", "marketing_start_date": "20250115"}], "brand_name": "Diclofenac Epolamine", "product_id": "82347-0405_41a96431-3fd8-a73e-e063-6294a90a5ec5", "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": "82347-0405", "generic_name": "Diclofenac Epolamine", "labeler_name": "YARAL Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Epolamine", "active_ingredients": [{"name": "DICLOFENAC EPOLAMINE", "strength": ".013 g/1"}], "application_number": "NDA021234", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20221118", "listing_expiration_date": "20261231"}