🇺🇸
United States · US · US:0378-4890_750bda83-d972-44e2-85ae-26676e1e7c34
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
- ndc11037848909330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)
Annotations
UNII (FDA Substance ID)
99DK7FVK1H
NEVIRAPINE
RxCUI 53654
Orange Book
A205651
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": "0378-4890_750bda83-d972-44e2-85ae-26676e1e7c34",
"productndc": "0378-4890",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "205651",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Oct 27, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEVIRAPINE",
"proprietary_name": "Nevirapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205651",
"marketing_category": "ANDA",
"nonproprietary_name": "nevirapine",
"start_marketing_date": "20141029",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AG01.
Access this data programmatically
Query Nevirapine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.