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United States · US · US:50090-0485_b4e41027-4beb-46cc-b12d-38fc3b6f357d

Tamoxifen Citrate

Orange BookUNIISPLATC L02BA01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeL02BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009004851
    60 TABLET in 1 BOTTLE (50090-0485-1)

Annotations

UNII (FDA Substance ID)
7FRV7310N6
TAMOXIFEN CITRATE
RxCUI 40137
Orange Book
A070929
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": "50090-0485_b4e41027-4beb-46cc-b12d-38fc3b6f357d",
  "productndc": "50090-0485",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070929",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Feb 20, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG 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": "ANDA070929",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamoxifen Citrate",
  "start_marketing_date": "20110815",
  "active_numerator_strength": "10"
}

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