Femring

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerMillicent US, Inc.

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7249520105
1 POUCH in 1 CARTON (72495-201-05) / 90 d in 1 POUCH

Annotations

UNII (FDA Substance ID)

5R97F5H93P

ESTRADIOL ACETATE

RxCUI 405416

Orange Book

N021367

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5R97F5H93P",
    "rxcui": "405416",
    "inchikey": "FHXBMXJMKMWVRG-SLHNCBLASA-N",
    "display_name": "ESTRADIOL ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "7aaa97f9-a9d1-c815-e053-2991aa0afb9e": {
      "match": "brand_token",
      "title": "FEMRING (ESTRADIOL ACETATE) RING [MILLICENT US, INC.]",
      "spl_version": "7",
      "published_date": "2025-12-19"
    }
  },
  "productid": "72495-201_544b4b70-8164-4cf8-845b-23635bda46e7",
  "productndc": "72495-201",
  "dosage_form": "RING",
  "orange_book": {
    "appl_no": "021367",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.05MG BASE/24HR",
        "product_no": "001",
        "approval_date": "Mar 20, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.1MG BASE/24HR",
        "product_no": "002",
        "approval_date": "Mar 20, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL ACETATE",
  "proprietary_name": "Femring",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA021367",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol acetate",
  "start_marketing_date": "20181210",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code G03CA03.

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