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United States · US · US:71610-247_a3c90a47-42cb-44b6-99e0-f027dc45ac2b
Entacapone
Orange BookUNIISPLATC N04BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN04BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171610247833600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83)
Annotations
UNII (FDA Substance ID)
4975G9NM6T
ENTACAPONE
RxCUI 60307
Orange Book
N020796
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4975G9NM6T",
"rxcui": "60307",
"inchikey": "JRURYQJSLYLRLN-BJMVGYQFSA-N",
"display_name": "ENTACAPONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"56327e32-3b06-4144-91a0-bb1908842e33": {
"match": "brand_token",
"title": "ENTACAPONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]",
"spl_version": "7",
"published_date": "2026-05-14"
}
},
"productid": "71610-247_a3c90a47-42cb-44b6-99e0-f027dc45ac2b",
"productndc": "71610-247",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020796",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Oct 19, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTACAPONE",
"proprietary_name": "Entacapone",
"active_ingred_unit": "mg/1",
"application_number": "NDA020796",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Entacapone",
"start_marketing_date": "20140604",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N04BX02.
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