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United States · US · US:0378-4050_af4a1dc3-d150-42dc-95ab-89d579f1725a
Nevirapine
Orange BookUNIISPLATC J05AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037840509160 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)
Annotations
UNII (FDA Substance ID)
99DK7FVK1H
NEVIRAPINE
RxCUI 53654
Orange Book
A202523
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "99DK7FVK1H",
"rxcui": "53654",
"inchikey": "NQDJXKOVJZTUJA-UHFFFAOYSA-N",
"display_name": "NEVIRAPINE",
"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": "0378-4050_af4a1dc3-d150-42dc-95ab-89d579f1725a",
"productndc": "0378-4050",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202523",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "May 22, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEVIRAPINE",
"proprietary_name": "Nevirapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202523",
"marketing_category": "ANDA",
"nonproprietary_name": "nevirapine",
"start_marketing_date": "20120522",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J05AG01.
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