Entecavir

Orange BookUNIISPLATC J05AF10

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ05AF10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6838292101
100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01)
ndc11
6838292106
30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06)
ndc11
6838292116
90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)
ndc11
6838292177
10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)

Annotations

UNII (FDA Substance ID)

5968Y6H45M

ENTECAVIR

RxCUI 306266

Orange Book

A206745

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": "68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73",
  "productndc": "68382-921",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206745",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Jun 23, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jun 23, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENTECAVIR",
  "proprietary_name": "Entecavir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206745",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Entecavir",
  "start_marketing_date": "20170810",
  "active_numerator_strength": "1"
}

Related drugs

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