ABIGALE LO

Orange BookUNIISPLATC G03CA

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

Identification

ManufacturerXiromed LLC

CountryUS (United States)

ATC codeG03CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070030385
3 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A207261

ABAB

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": {
    "df013d36-de10-0607-7e12-95ed43bf7ee9": {
      "match": "brand_token",
      "title": "ABIGALE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET ABIGALE LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [XIROMED LLC]",
      "spl_version": "1",
      "published_date": "2025-03-06"
    }
  },
  "productid": "70700-303_35d8f763-8f98-f5ea-fae8-1367b638e82c",
  "productndc": "70700-303",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207261",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG;0.1MG",
        "product_no": "001",
        "approval_date": "Feb 10, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG;0.5MG",
        "product_no": "002",
        "approval_date": "Feb 10, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
  "proprietary_name": "ABIGALE LO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207261",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estradiol and norethindrone acetate",
  "start_marketing_date": "20250129",
  "active_numerator_strength": ".5; .1"
}

Related drugs

Other records sharing ATC code G03CA.

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