estrogens, conjugated

Orange BookUNIISPLATC G03CA57

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeG03CA57

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5074238901
100 TABLET, FILM COATED in 1 BOTTLE (50742-389-01)
ndc11
5074238910
1000 TABLET, FILM COATED in 1 BOTTLE (50742-389-10)

Annotations

UNII (FDA Substance ID)

IU5QR144QX

ESTROGENS, CONJUGATED

RxCUI 4099

Orange Book

A214025

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IU5QR144QX",
    "rxcui": "4099",
    "inchikey": null,
    "display_name": "ESTROGENS, CONJUGATED",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b17eca23-f387-4243-a76a-bcf6b88aeef9": {
      "match": "brand_token",
      "title": "ESTROGENS, CONJUGATED TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "1",
      "published_date": "2025-11-21"
    }
  },
  "productid": "50742-389_420e847b-9359-4557-be3e-8b0c8cb3203b",
  "productndc": "50742-389",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214025",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.45MG",
        "product_no": "002",
        "approval_date": "Oct 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.625MG",
        "product_no": "003",
        "approval_date": "Oct 15, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTROGENS, CONJUGATED",
  "proprietary_name": "estrogens, conjugated",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214025",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estrogens, conjugated",
  "start_marketing_date": "20251016",
  "active_numerator_strength": ".625"
}

Related drugs

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