ENTECAVIR

Orange BookUNIISPLATC J05AF10

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

Identification

ManufacturerYaopharma Co., Ltd.

CountryUS (United States)

ATC codeJ05AF10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5077101301
30 TABLET, FILM COATED in 1 BOTTLE (50771-013-01)
ndc11
5077101302
90 TABLET, FILM COATED in 1 BOTTLE (50771-013-02)

Annotations

UNII (FDA Substance ID)

5968Y6H45M

ENTECAVIR

RxCUI 306266

Orange Book

A212201

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5968Y6H45M",
    "rxcui": "306266",
    "inchikey": "YXPVEXCTPGULBZ-WQYNNSOESA-N",
    "display_name": "ENTECAVIR",
    "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": "50771-013_4502e388-5064-bd87-e063-6294a90a4b1c",
  "productndc": "50771-013",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212201",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENTECAVIR",
  "proprietary_name": "ENTECAVIR",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212201",
  "marketing_category": "ANDA",
  "nonproprietary_name": "entecavir",
  "start_marketing_date": "20230701",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code J05AF10.

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