ENTECAVIR

Orange BookUNIISPLATC J05AF10

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

Identification

ManufacturerSolco Healthcare LLC

CountryUS (United States)

ATC codeJ05AF10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4354743603
30 TABLET, FILM COATED in 1 BOTTLE (43547-436-03)
ndc11
4354743609
90 TABLET, FILM COATED in 1 BOTTLE (43547-436-09)
ndc11
4354743650
500 TABLET, FILM COATED in 1 BOTTLE (43547-436-50)

Annotations

UNII (FDA Substance ID)

NNU2O4609D

ENTECAVIR ANHYDROUS

RxCUI 1546027

Orange Book

A208782

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": "43547-436_a5a51ce6-2c18-40de-b266-c3891132bbd1",
  "productndc": "43547-436",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208782",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Oct 10, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 10, 2017"
      }
    ],
    "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": "ANDA208782",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ENTECAVIR",
  "start_marketing_date": "20180401",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code J05AF10.

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