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United States · US · US:51862-645_0048909e-ca81-45c9-9f5c-c5891f9bc85e

Nymyo

Orange Book

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

Identification

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

Packs · 4

  • ndc11
    5186264501
    1 BLISTER PACK in 1 PACKET (51862-645-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186264502
    1 BLISTER PACK in 1 CARTON (51862-645-02) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186264503
    3 BLISTER PACK in 1 CARTON (51862-645-03) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186264506
    6 BLISTER PACK in 1 CARTON (51862-645-06) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A090523
AB
Raw payload (JSON)
{
  "route": null,
  "productid": "51862-645_0048909e-ca81-45c9-9f5c-c5891f9bc85e",
  "productndc": "51862-645",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090523",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.25MG",
        "product_no": "001",
        "approval_date": "May 23, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Nymyo",
  "active_ingred_unit": null,
  "application_number": "ANDA090523",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20201011",
  "active_numerator_strength": null
}

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