Entecavir

Orange BookUNIISPLATC J05AF10

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeJ05AF10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6586284130
1 BOTTLE in 1 CARTON (65862-841-30) / 30 TABLET in 1 BOTTLE
ndc11
6586284190
1 BOTTLE in 1 CARTON (65862-841-90) / 90 TABLET in 1 BOTTLE
ndc11
6586284199
1 BOTTLE in 1 CARTON (65862-841-99) / 1000 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

5968Y6H45M

ENTECAVIR

RxCUI 306266

Orange Book

A206217

ABAB

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": "65862-841_81e4395b-8a3e-466e-b039-0a804f171b43",
  "productndc": "65862-841",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206217",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENTECAVIR",
  "proprietary_name": "Entecavir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206217",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Entecavir",
  "start_marketing_date": "20150826",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code J05AF10.

Access this data programmatically

Query Entecavir and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs