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United States · US · US:60846-232_ec312506-ea70-4aa1-8c07-0347fe956a57

Activella

Orange BookUNIISPLATC G03CA

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6084623201
    1 BLISTER PACK in 1 CARTON (60846-232-01) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N020907
AB
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": {
    "d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0": {
      "match": "brand_token",
      "title": "ACTIVELLA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "18",
      "published_date": "2024-06-03"
    }
  },
  "productid": "60846-232_ec312506-ea70-4aa1-8c07-0347fe956a57",
  "productndc": "60846-232",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020907",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG;0.5MG",
        "product_no": "001",
        "approval_date": "Nov 18, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Dec 28, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
  "proprietary_name": "Activella",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020907",
  "marketing_category": "NDA",
  "nonproprietary_name": "Estradiol/norethindrone acetate",
  "start_marketing_date": "20190501",
  "active_numerator_strength": "1; .5"
}

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