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United States · US · US:50419-483_261d4ace-5c4e-48f6-b793-354492017e89

Angeliq

In shortageOrange BookUNIISPLATC G03AC

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

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5041948303
    3 BLISTER PACK in 1 CARTON (50419-483-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-01)
  • ndc11
    5041948372
    1 BLISTER PACK in 1 CARTON (50419-483-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-71)

Annotations

UNII (FDA Substance ID)
N295J34A25
DROSPIRENONE
RxCUI 11636
Orange Book
N021355
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Drospirenone; Ethinyl Estradiol Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "N295J34A25",
    "rxcui": "11636",
    "inchikey": "METQSPRSQINEEU-HXCATZOESA-N",
    "display_name": "DROSPIRENONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "761834c2-6b61-4583-84c2-f1ca4a97c4f2": {
      "match": "brand_token",
      "title": "ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "20",
      "published_date": "2026-03-03"
    }
  },
  "productid": "50419-483_261d4ace-5c4e-48f6-b793-354492017e89",
  "productndc": "50419-483",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021355",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.25MG;0.5MG",
        "product_no": "001",
        "approval_date": "Feb 29, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG;1MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DROSPIRENONE; ESTRADIOL",
  "shortage_reason": "Drospirenone; Ethinyl Estradiol Tablet",
  "shortage_status": "current",
  "proprietary_name": "Angeliq",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021355",
  "marketing_category": "NDA",
  "nonproprietary_name": "drospirenone and estradiol",
  "start_marketing_date": "20051128",
  "active_numerator_strength": ".5; 1"
}

Related drugs

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