🇺🇸
United States · US · US:0781-5613_2176ea25-da6b-47b2-a081-b3da614df0a0
Carbidopa, Levodopa, and Entacapone
Orange BookSPLATC N04BX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN04BX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110781561301100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01)
Annotations
Orange Book
N021485
ABABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b": {
"match": "brand_token",
"title": "CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
"spl_version": "2",
"published_date": "2026-04-27"
}
},
"productid": "0781-5613_2176ea25-da6b-47b2-a081-b3da614df0a0",
"productndc": "0781-5613",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021485",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "12.5MG;200MG;50MG",
"product_no": "001",
"approval_date": "Jun 11, 2003"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG;200MG;100MG",
"product_no": "002",
"approval_date": "Jun 11, 2003"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "37.5MG;200MG;150MG",
"product_no": "003",
"approval_date": "Jun 11, 2003"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG;200MG;200MG",
"product_no": "004",
"approval_date": "Aug 2, 2007"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "18.75MG;200MG;75MG",
"product_no": "005",
"approval_date": "Aug 29, 2008"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "31.25MG;200MG;125MG",
"product_no": "006",
"approval_date": "Aug 29, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"proprietary_name": "Carbidopa, Levodopa, and Entacapone",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA021485",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Carbidopa, Levodopa, and Entacapone",
"start_marketing_date": "20140618",
"active_numerator_strength": "12.5; 200; 50"
}Related drugs
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