Entecavir

Orange BookUNIISPLATC J05AF10

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEpic Pharma, LLC

CountryUS (United States)

ATC codeJ05AF10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4280666830
1 BOTTLE in 1 CARTON (42806-668-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

NNU2O4609D

ENTECAVIR ANHYDROUS

RxCUI 1546027

Orange Book

A216857

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "NNU2O4609D",
    "rxcui": "1546027",
    "inchikey": "QDGZDCVAUDNJFG-FXQIFTODSA-N",
    "display_name": "ENTECAVIR ANHYDROUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5a1cbf7e-0352-aa3b-080c-222a6423ecd8": {
      "match": "brand_token",
      "title": "ENTECAVIR TABLET, FILM COATED [AVKARE]",
      "spl_version": "13",
      "published_date": "2026-05-15"
    }
  },
  "productid": "42806-668_d69451df-e204-4a5c-a2bb-9e6d4d519302",
  "productndc": "42806-668",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216857",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Dec 23, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENTECAVIR ANHYDROUS",
  "proprietary_name": "Entecavir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216857",
  "marketing_category": "ANDA",
  "nonproprietary_name": "entecavir",
  "start_marketing_date": "20221031",
  "active_numerator_strength": "1"
}

Related drugs

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