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United States · US · US:31722-833_2b442999-71b5-88f6-e063-6394a90a9d6e

Entecavir

Orange BookUNIISPLATC J05AF10

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AF10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    3172283330
    30 TABLET in 1 BOTTLE (31722-833-30)
  • ndc11
    3172283331
    10 TABLET in 1 BLISTER PACK (31722-833-31)
  • ndc11
    3172283332
    100 TABLET in 1 CARTON (31722-833-32)
  • ndc11
    3172283390
    90 TABLET in 1 BOTTLE (31722-833-90)

Annotations

UNII (FDA Substance ID)
NNU2O4609D
ENTECAVIR ANHYDROUS
RxCUI 1546027
Orange Book
A205740
ABAB
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": "31722-833_2b442999-71b5-88f6-e063-6394a90a9d6e",
  "productndc": "31722-833",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205740",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Aug 21, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Aug 21, 2015"
      }
    ],
    "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": "ANDA205740",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Entecavir",
  "start_marketing_date": "20150821",
  "active_numerator_strength": ".5"
}

Related drugs

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