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United States · US · US:65862-654_54466878-6cce-44e7-8188-27b6091a5d15
Entacapone
Orange BookUNIISPLATC N04BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN04BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586265401100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)
- ndc1165862654991000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)
Annotations
UNII (FDA Substance ID)
4975G9NM6T
ENTACAPONE
RxCUI 60307
Orange Book
A203437
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": "65862-654_54466878-6cce-44e7-8188-27b6091a5d15",
"productndc": "65862-654",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203437",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jun 19, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTACAPONE",
"proprietary_name": "Entacapone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203437",
"marketing_category": "ANDA",
"nonproprietary_name": "Entacapone",
"start_marketing_date": "20150619",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N04BX02.
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