🇺🇸
United States · US · US:65862-057_fd37e474-7411-4466-bf46-36fc74ef6684
Nevirapine
Orange BookUNIISPLATC J05AG
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AG
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586205711100 mL in 1 BOTTLE (65862-057-11)
- ndc116586205724240 mL in 1 BOTTLE (65862-057-24)
Annotations
UNII (FDA Substance ID)
B7XF2TD73C
NEVIRAPINE HEMIHYDRATE
RxCUI 2462459
Orange Book
A077702
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B7XF2TD73C",
"rxcui": "2462459",
"inchikey": "KMTLSXAXTLQBKJ-UHFFFAOYSA-N",
"display_name": "NEVIRAPINE HEMIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fbd628db-4076-4fe0-8323-9cc33ae92e42": {
"match": "brand_token",
"title": "NEVIRAPINE (NEVIRAPINE) TABLET [MICRO LABS LIMITED]",
"spl_version": "13",
"published_date": "2025-11-17"
}
},
"productid": "65862-057_fd37e474-7411-4466-bf46-36fc74ef6684",
"productndc": "65862-057",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "077702",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "May 22, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEVIRAPINE HEMIHYDRATE",
"proprietary_name": "Nevirapine",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA077702",
"marketing_category": "ANDA",
"nonproprietary_name": "Nevirapine",
"start_marketing_date": "20120522",
"active_numerator_strength": "50"
}Related drugs
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Access this data programmatically
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