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United States · US · US:50228-460_cea3f5f1-014d-0c1d-e053-2995a90a7f01
Carbidopa and Levodopa
Orange BookSPLATC N04BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals Inc
CountryUS (United States)
ATC codeN04BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115022846001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-01)
- ndc1150228460101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-10)
- ndc11502284603030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-30)
Annotations
Orange Book
A214091
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"87ab55c9-203d-d595-3e3e-0e38f2f6d9c4": {
"match": "brand_token",
"title": "CARBIDOPA AND LEVODOPA TABLET [DR. REDDY'S LABORATORIES INC]",
"spl_version": "4",
"published_date": "2026-05-21"
}
},
"productid": "50228-460_cea3f5f1-014d-0c1d-e053-2995a90a7f01",
"productndc": "50228-460",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "214091",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;100MG",
"product_no": "001",
"approval_date": "Oct 5, 2021"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG;200MG",
"product_no": "002",
"approval_date": "Oct 5, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARBIDOPA; LEVODOPA",
"proprietary_name": "Carbidopa and Levodopa",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214091",
"marketing_category": "ANDA",
"nonproprietary_name": "Carbidopa and Levodopa",
"start_marketing_date": "20211005",
"active_numerator_strength": "25; 100"
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