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United States · US · US:0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4b

Mimvey

Orange BookUNIISPLATC G03CA

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0093545528
    1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0093545542
    5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A079193
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": {
    "b1c5c06b-9ce2-4bf7-9693-e37608055a14": {
      "match": "brand_token",
      "title": "MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "16",
      "published_date": "2024-07-19"
    }
  },
  "productid": "0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4b",
  "productndc": "0093-5455",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079193",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG;0.5MG",
        "product_no": "001",
        "approval_date": "May 11, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
  "proprietary_name": "Mimvey",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079193",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol and Norethindrone Acetate",
  "start_marketing_date": "20100602",
  "active_numerator_strength": "1; .5"
}

Related drugs

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