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United States · US · US:71335-0445_5f5f09d7-aaf1-4926-9ed5-7bc5f3fa20b6

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
    7133504451
    100 TABLET in 1 BOTTLE (71335-0445-1)
  • ndc11
    7133504452
    30 TABLET in 1 BOTTLE (71335-0445-2)
  • ndc11
    7133504453
    90 TABLET in 1 BOTTLE (71335-0445-3)
  • ndc11
    7133504454
    60 TABLET in 1 BOTTLE (71335-0445-4)
  • ndc11
    7133504455
    180 TABLET in 1 BOTTLE (71335-0445-5)
  • ndc11
    7133504456
    120 TABLET in 1 BOTTLE (71335-0445-6)
  • ndc11
    7133504457
    28 TABLET in 1 BOTTLE (71335-0445-7)

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A040197
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": "71335-0445_5f5f09d7-aaf1-4926-9ed5-7bc5f3fa20b6",
  "productndc": "71335-0445",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040197",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Oct 22, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 22, 1997"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Oct 22, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040197",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "19971028",
  "active_numerator_strength": "1"
}

Related drugs

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