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United States · US · US:51079-978_3a39bb13-44d1-2652-e063-6294a90ad211
Carbidopa and Levodopa
Orange BookSPLATC N04BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional Inc.
CountryUS (United States)
ATC codeN04BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115107997820100 BLISTER PACK in 1 CARTON (51079-978-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-978-01)
Annotations
Orange Book
A075091
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": "51079-978_3a39bb13-44d1-2652-e063-6294a90ad211",
"productndc": "51079-978",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075091",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG;200MG",
"product_no": "001",
"approval_date": "Sep 30, 1999"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;100MG",
"product_no": "002",
"approval_date": "Apr 21, 2000"
}
],
"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": "ANDA075091",
"marketing_category": "ANDA",
"nonproprietary_name": "carbidopa and levodopa",
"start_marketing_date": "20020201",
"active_numerator_strength": "25; 100"
}Related drugs
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