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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

  • ndc11
    6586205711
    100 mL in 1 BOTTLE (65862-057-11)
  • ndc11
    6586205724
    240 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

Other records sharing ATC code J05AG.

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