norethindrone acetate and ethinyl estradiol and ferrous fumarate

Orange BookSPL

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846237629
3 BLISTER PACK in 1 CARTON (68462-376-29) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A210369

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
      "match": "brand_token",
      "title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "7",
      "published_date": "2026-03-27"
    }
  },
  "productid": "68462-376_c38d6eb8-e70a-415a-ae54-daf53998112a",
  "productndc": "68462-376",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "210369",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Dec 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate",
  "active_ingred_unit": null,
  "application_number": "ANDA210369",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate",
  "start_marketing_date": "20171226",
  "active_numerator_strength": null
}

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