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United States · US · US:33342-260_000701ed-32a2-4b57-acb3-41c3b5ad869e
Entacapone
Orange BookUNIISPLATC N04BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeN04BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc113334226011100 TABLET in 1 BOTTLE (33342-260-11)
- ndc113334226015500 TABLET in 1 BOTTLE (33342-260-15)
Annotations
UNII (FDA Substance ID)
4975G9NM6T
ENTACAPONE
RxCUI 60307
Orange Book
A207210
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": "33342-260_000701ed-32a2-4b57-acb3-41c3b5ad869e",
"productndc": "33342-260",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207210",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jun 5, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTACAPONE",
"proprietary_name": "Entacapone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207210",
"marketing_category": "ANDA",
"nonproprietary_name": "Entacapone",
"start_marketing_date": "20170606",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N04BX02.
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