BARACLUDE

Orange BookUNIISPLATC J05AF10

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

Identification

ManufacturerE.R. Squibb & Sons, L.L.C.

CountryUS (United States)

ATC codeJ05AF10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0003161212
1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

5968Y6H45M

ENTECAVIR

RxCUI 306266

Orange Book

N021797

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": {
    "046e61c9-9298-4b2e-b76e-b26b81fecd20": {
      "match": "brand_token",
      "title": "BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "42",
      "published_date": "2025-12-22"
    }
  },
  "productid": "0003-1612_275a2584-65d6-40f8-8aac-49eb54479f6d",
  "productndc": "0003-1612",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021797",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Mar 29, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Mar 29, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENTECAVIR",
  "proprietary_name": "BARACLUDE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021797",
  "marketing_category": "NDA",
  "nonproprietary_name": "entecavir",
  "start_marketing_date": "20050329",
  "active_numerator_strength": "1"
}

Related drugs

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