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United States · US · US:33342-004_99d52ed2-f3e5-476a-8ba6-ed2cee3aae8a
Nevirapine
Orange BookUNIISPLATC J05AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11333420040960 TABLET in 1 BOTTLE (33342-004-09)
Annotations
UNII (FDA Substance ID)
99DK7FVK1H
NEVIRAPINE
RxCUI 53654
Orange Book
A090688
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": "33342-004_99d52ed2-f3e5-476a-8ba6-ed2cee3aae8a",
"productndc": "33342-004",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090688",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jan 14, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEVIRAPINE",
"proprietary_name": "Nevirapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090688",
"marketing_category": "ANDA",
"nonproprietary_name": "Nevirapine",
"start_marketing_date": "20190128",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J05AG01.
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