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United States · US · US:52817-392_f8d2095e-d709-7b97-e053-6294a90af7d6
Carbidopa-levodopa
Orange BookSPLATC N04BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTruPharma, LLC
CountryUS (United States)
ATC codeN04BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1152817392001000 TABLET in 1 BOTTLE (52817-392-00)
- ndc115281739210100 TABLET in 1 BOTTLE (52817-392-10)
- ndc115281739250500 TABLET in 1 BOTTLE (52817-392-50)
Annotations
Orange Book
A216505
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"9e3c796b-2e68-4bcc-b927-18a58bea4703": {
"match": "brand_token",
"title": "CARBIDOPA-LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET [ADVAGEN PHARMA LTD.,]",
"spl_version": "5",
"published_date": "2026-05-13"
}
},
"productid": "52817-392_f8d2095e-d709-7b97-e053-6294a90af7d6",
"productndc": "52817-392",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216505",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;100MG",
"product_no": "001",
"approval_date": "Sep 21, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;100MG",
"product_no": "002",
"approval_date": "Sep 21, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;250MG",
"product_no": "003",
"approval_date": "Sep 21, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARBIDOPA; LEVODOPA",
"proprietary_name": "Carbidopa-levodopa",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216505",
"marketing_category": "ANDA",
"nonproprietary_name": "carbidopa and levodopa",
"start_marketing_date": "20220921",
"active_numerator_strength": "25; 250"
}Related drugs
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