🇺🇸
United States · US · US:82347-0405_41a96431-3fd8-a73e-e063-6294a90a5ec5
Diclofenac Epolamine
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerYARAL Pharma Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182347040556 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4)
- ndc1182347040563 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4)
Annotations
UNII (FDA Substance ID)
X5F8EKL9ZG
DICLOFENAC EPOLAMINE
RxCUI 40968
Orange Book
N021234
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X5F8EKL9ZG",
"rxcui": "40968",
"inchikey": "DCERVXIINVUMKU-UHFFFAOYSA-N",
"display_name": "DICLOFENAC EPOLAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"86461915-9bc1-43d4-8d92-6eef3e56bd90": {
"match": "brand_token",
"title": "DICLOFENAC POTASSIUM TABLET, COATED [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-06-01"
}
},
"productid": "82347-0405_41a96431-3fd8-a73e-e063-6294a90a5ec5",
"productndc": "82347-0405",
"dosage_form": "SYSTEM",
"orange_book": {
"appl_no": "021234",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.3%",
"product_no": "001",
"approval_date": "Jan 31, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICLOFENAC EPOLAMINE",
"proprietary_name": "Diclofenac Epolamine",
"active_ingred_unit": "g/1",
"application_number": "NDA021234",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Diclofenac Epolamine",
"start_marketing_date": "20221118",
"active_numerator_strength": ".013"
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