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United States · US · US:71335-2387_163b7c0d-6b69-4ca2-bc23-b60e268bc176

Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG03CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7133523871
    100 TABLET in 1 BOTTLE (71335-2387-1)
  • ndc11
    7133523872
    30 TABLET in 1 BOTTLE (71335-2387-2)
  • ndc11
    7133523873
    90 TABLET in 1 BOTTLE (71335-2387-3)
  • ndc11
    7133523874
    60 TABLET in 1 BOTTLE (71335-2387-4)
  • ndc11
    7133523875
    180 TABLET in 1 BOTTLE (71335-2387-5)
  • ndc11
    7133523876
    120 TABLET in 1 BOTTLE (71335-2387-6)
  • ndc11
    7133523877
    28 TABLET in 1 BOTTLE (71335-2387-7)

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A217334
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4TI98Z838E",
    "rxcui": "4083",
    "inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
    "display_name": "ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "50c786d6-91bd-4eea-9455-ff2abc08372f": {
      "match": "brand_token",
      "title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71335-2387_163b7c0d-6b69-4ca2-bc23-b60e268bc176",
  "productndc": "71335-2387",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217334",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Sep 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Sep 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Sep 6, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217334",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20230906",
  "active_numerator_strength": "1"
}

Related drugs

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