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United States · US · US:68180-602_0852eda3-c1d3-426d-b73d-c7f08dfd9584

Lamivudine

Orange BookUNIISPLATC J05AF05

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AF05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
A205217
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2T8Q726O95",
    "rxcui": "68244",
    "inchikey": "JTEGQNOMFQHVDC-NKWVEPMBSA-N",
    "display_name": "LAMIVUDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6fd4d6b9-65ea-4988-8d6f-dd220ec5052d": {
      "match": "brand_token",
      "title": "LAMIVUDINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]",
      "spl_version": "5",
      "published_date": "2026-03-20"
    }
  },
  "productid": "68180-602_0852eda3-c1d3-426d-b73d-c7f08dfd9584",
  "productndc": "68180-602",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205217",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Dec 18, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE",
  "proprietary_name": "Lamivudine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205217",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamivudine",
  "start_marketing_date": "20150325",
  "active_numerator_strength": "150"
}

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