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United States · US · US:33342-238_de3914b8-5c5c-4b11-a9f9-39f592d51c1d

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

  • ndc11
    3334223807
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)

Annotations

UNII (FDA Substance ID)
99DK7FVK1H
NEVIRAPINE
RxCUI 53654
Orange Book
A206879
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": "33342-238_de3914b8-5c5c-4b11-a9f9-39f592d51c1d",
  "productndc": "33342-238",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206879",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEVIRAPINE",
  "proprietary_name": "NEVIRAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206879",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NEVIRAPINE",
  "start_marketing_date": "20171007",
  "active_numerator_strength": "400"
}

Related drugs

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