Entecavir

Orange BookUNIISPLATC J05AF10

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

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
3172283430
30 TABLET in 1 BOTTLE (31722-834-30)
ndc11
3172283431
10 TABLET in 1 BLISTER PACK (31722-834-31)
ndc11
3172283432
100 TABLET in 1 CARTON (31722-834-32)
ndc11
3172283490
90 TABLET in 1 BOTTLE (31722-834-90)

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": "31722-834_2b442999-71b5-88f6-e063-6394a90a9d6e",
  "productndc": "31722-834",
  "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": "1"
}

Related drugs

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