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United States · US · US:70771-1777_81ceed98-7fc6-416f-8787-08cbdd76a856

norelgestromin and ethinyl estradiol

In shortageOrange BookUNIISPLATC G03CA

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7077117773
    3 POUCH in 1 CARTON (70771-1777-3) / 1 POUCH in 1 POUCH (70771-1777-1) / 7 mg in 1 POUCH

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A214594
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Ethinyl Diacetate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "423D2T571U",
    "rxcui": "4124",
    "inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
    "display_name": "ETHINYL ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9": {
      "match": "brand_token",
      "title": "NORELGESTROMIN AND ETHINYL ESTRADIOL PATCH [ZYDUS LIFESCIENCES LIMITED]",
      "spl_version": "2",
      "published_date": "2026-04-17"
    }
  },
  "productid": "70771-1777_81ceed98-7fc6-416f-8787-08cbdd76a856",
  "productndc": "70771-1777",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "214594",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG/24HR;0.15MG/24HR",
        "product_no": "001",
        "approval_date": "Sep 14, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; NORELGESTROMIN",
  "shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
  "shortage_status": "current",
  "proprietary_name": "norelgestromin and ethinyl estradiol",
  "active_ingred_unit": "ug/mg; ug/mg",
  "application_number": "ANDA214594",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norelgestromin and ethinyl estradiol",
  "start_marketing_date": "20231121",
  "active_numerator_strength": "35; 150"
}

Related drugs

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