diclofenac epolamine

Generic: diclofenac epolamine

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac epolamine
Generic Name diclofenac epolamine
Labeler advanced rx of tennessee, llc
Dosage Form SYSTEM
Routes
TOPICAL
Active Ingredients

diclofenac epolamine .013 g/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0364
Product ID 80425-0364_2a994ea2-2577-6513-e063-6394a90a7bc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021234
Listing Expiration 2026-12-31
Marketing Start 2023-11-27

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 804250364
Hyphenated Format 80425-0364

Supplemental Identifiers

RxCUI
855626
UNII
X5F8EKL9ZG

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 (80425-0364-1) / 5 SYSTEM in 1 POUCH
source: ndc

Packages (1)

80425-0364-1 6 POUCH in 1 CARTON (80425-0364-1) / 5 SYSTEM in 1 POUCH

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": "2a994ea2-2577-6513-e063-6394a90a7bc2", "openfda": {"unii": ["X5F8EKL9ZG"], "rxcui": ["855626"], "spl_set_id": ["08b8737f-b6d2-77da-e063-6294a90a1a3e"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (80425-0364-1)  / 5 SYSTEM in 1 POUCH", "package_ndc": "80425-0364-1", "marketing_start_date": "20231127"}], "brand_name": "diclofenac epolamine", "product_id": "80425-0364_2a994ea2-2577-6513-e063-6394a90a7bc2", "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": "80425-0364", "generic_name": "diclofenac epolamine", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20231127", "listing_expiration_date": "20261231"}