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United States · US · US:59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5

Zumandimine

Orange BookSPL

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5965103028
    1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5965103085
    3 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5965103087
    1 POUCH in 1 CARTON (59651-030-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • ndc11
    5965103088
    3 POUCH in 1 CARTON (59651-030-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A209407
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "192ad3b0-9ef2-409d-a851-77712202c45a": {
      "match": "brand_token",
      "title": "ZUMANDIMINE (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "10",
      "published_date": "2023-11-02"
    }
  },
  "productid": "59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5",
  "productndc": "59651-030",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.03MG",
        "product_no": "001",
        "approval_date": "Mar 26, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Zumandimine",
  "active_ingred_unit": null,
  "application_number": "ANDA209407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Drospirenone and Ethinyl Estradiol",
  "start_marketing_date": "20180326",
  "active_numerator_strength": null
}

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