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United States · US · US:0378-0274_2c1fe025-1eb2-4b2f-b8c9-5d0cfc3c683e

Tamoxifen Citrate

Orange BookUNIISPLATC L02BA01

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL02BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378027493
    30 TABLET in 1 BOTTLE (0378-0274-93)

Annotations

UNII (FDA Substance ID)
7FRV7310N6
TAMOXIFEN CITRATE
RxCUI 40137
Orange Book
A074732
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7FRV7310N6",
    "rxcui": "40137",
    "inchikey": "FQZYTYWMLGAPFJ-OQKDUQJOSA-N",
    "display_name": "TAMOXIFEN CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "509f8ba3-214d-aec8-e063-6294a90af498": {
      "match": "brand_token",
      "title": "TAMOXIFEN CITRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-05-04"
    }
  },
  "productid": "0378-0274_2c1fe025-1eb2-4b2f-b8c9-5d0cfc3c683e",
  "productndc": "0378-0274",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074732",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Feb 20, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Feb 20, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAMOXIFEN CITRATE",
  "proprietary_name": "Tamoxifen Citrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074732",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamoxifen Citrate",
  "start_marketing_date": "20030220",
  "active_numerator_strength": "20"
}

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